Tag Archive for: Requirements & Requirements Management

QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485

Prepare for QMSR: Step-by-Step Guidance for FDA’s ISO 13485 Alignment

The FDA’s long-anticipated Quality Management System Regulation (QMSR) goes into effect in February 2026, marking a major shift by aligning FDA requirements with ISO 13485. This update presents both challenges and opportunities to streamline your quality processes while meeting new compliance expectations.

In this webinar, Steve Keverline, Principal Advisor at RQM+, and Tom Rish, Senior Product Marketing Manager at Jama Software, break down key changes, share strategies for companies at all stages of ISO 13485 adoption, and provide actionable tools to help you prepare.

Whether you’re just beginning your QMSR journey or fine-tuning a mature system, this session will equip you with the clarity and direction needed for QMSR success.

Key Takeaways:

  • What is QMSR, why is the FDA aligning with ISO 13485, and what does this mean for your business?
  • The key elements of ISO 13485 that are critical to QMSR-readiness.
  • Strategies for both early adopters and seasoned organizations adjusting to QMSR-specific requirements.
  • Best practices to align design control and risk management activities.
  • Step-by-step insights, including leveraging integrated software tools to enhance risk management and traceability.

Don’t wait for 2026. Start preparing now to reduce risk, increase efficiency, and confidently lead your team through this regulatory shift.

 

Steve Keverline: Thanks to everyone in attendance of today’s webinar. My name’s Steve Keverline, I’m a principal advisor at RQM+, and today I’ll be walking through how to prepare for FDA’s alignment with ISO 13485. This is the QMSR initiative with an effective date of February 2026, so roughly six months away, quickly coming upon us and just highlighting that this shift really represents one of the most significant regulatory updates in, I’ll say, decades. So, really, the US medical device manufacturer was updated. Well, in 1996 was the large update. So, today’s goal is really to help understand what’s changing, what to expect, and how to prepare effectively for the transition to QMSR.

And what I have up here on the screen is an outline of what I will be covering today. I’ll be doing a little bit of background on the QMSR, well, more specifically, a little background on the QSR and 13485, just how they came about, and why they’re relevant to what we’ll talk about today. Why is FDA aligning with 13485, key elements to watch or maybe watch out for, and the transition timeline. Next, we’ll talk about the QMSR impact and adoption, so impact of this change will really vary greatly depending on the markets you currently sell into and really the maturity of your quality management system. So, we’ll touch on that. Certainly, if you’re selling into the US and not currently certified as ISO 13485, you have a heavy lift. If you’re already ISO 13485 certified currently selling in the US, then probably a little bit more administrative but we’ll cover those two scenarios.

And then just some implementation guidance, so just some thoughts on implementation best practices. So, one of the key pieces is integration of risk management and design control so we’ll spend some time on that, just really looking at how best to do that. Some common pitfalls, how to avoid them, and, finally, some tips on preparation and planning.

All right, QMS refresher. Yeah, so for those newer to medical devices or not yet familiar with the quality management system regulation, I thought it’d be beneficial just to step back a little bit and start with some background information on the quality system regulation, otherwise known as QSR or FDA 21 CFR Part 820. Compliance for the QSR is mandatory for commercializing a medical device in the US unless your product is identified or referred to as GMP-exempt. GMP-exempt is really applicable, really, only to lower risk, non-sterile medical devices, examples would be a tongue depressor, elastic bandage, manual toothbrush, bedpans, those type of low-risk devices. And even if GMP-exempt, there still are a subset of requirements like record keeping and complaint requirements.

The original, I’ll say original, the initial QSR took effect in 1978 and had significant revisions in 1996. And if you go back to those revisions, they were primarily due to product recalls that occurred in the field since the initial effective date back in … When it was originally released. And those recalls were primarily due to insufficient design controls and supplier controls so it became a big emphasis in 1996 to incorporate those elements within the QSR. Also, at the same time, ISO was starting to form, so the ISO committee had a draft of ISO 13485, and, go figure, the two just missed each other. So, the QSR came out, the ISO 13485 revision was published a little thereafter, so missed there in 1996. But you’ll see, and we’ll get into this a little bit more often as we go through this, but the ISO 13485 has evolved over time since then, there was a major update in 2003 and then a significant update in 2016. So, you can see that, while the QSR was a little stagnant, 13485 has been keeping up and has evolved over the last 30 years.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Keverline: When looking at the key set of requirements, the QSR tends to be a higher level set of requirements and not very prescriptive. When I’m challenged with interpreting the QSR, I have a colleague I work closely with, and she always says, “Well, let’s go to the preamble. Let’s really try to understand what FDA was thinking at the time.” So, not always obvious or intuitive, requires a little bit of what were they thinking, how do I interpret this with the QSR. [inaudible 00:07:19] come back here. And then 13485.

So, I touched on that a little bit in the last slide, 13485 provides a little more context regarding the requirements, is more prescriptive than the QSR. ISO, ISO stands for the International Organization for Standardization, so it’s different, it’s an independent non-governmental international organization. ISO publishes 13485 standards as well as other numerous system process product technical standards. Like I mentioned, the current version is March 2016, was published in March 2016, it’s titled Quality Management System requirements for medical devices intended for regulatory purposes and really covers the full product lifecycle. So, design and development, transfer, production, installation, servicing, really, throughout that full medical device useful life including post-market and decommissioning.

And also, ISO 13485 serves as really the foundation for most QMS frameworks outside the United States and certainly, in the European Union, it’s most recognized in specific to support CE marketing. So, key motivations, really, for FDA aligning with ISO 13485, it is the concept of harmonization. So, it didn’t happen back in 1996, had the best intent but it didn’t come together so here we are today with this initiative to align these two. And again, over the years, they’ve become more and more aligned with 2003 and then 2016 version. So this really means that manufacturers don’t need to maintain two sets of requirements. The regulations I mentioned a little bit earlier, a little outdated. So, QSR largely unchanged since 1996, a little static, 13485, definitely more dynamic and indescriptive, don’t need to go back to the preamble.

And there’s actually a really great … AAMI publishes a really great 13485 practical guide so, those that are new to 13485, really excellent, provides great examples and gives you a little bit more description on what the intent is. Efficiency for industry and FDA, so harmonization streamlines compliance, eliminating redundant efforts, this ultimately enables FDA to focus on risk-based oversight rather than duplicate inspections. Number four, regulatory clarity, so incorporating 13485 by reference provides a clearer, more direct international recognized framework. And it’s also important to note that there are some FDA specific requirements so, in some cases, there’s still FDA will take precedence over some of the 13485 requirements and we’ll get into that in a little bit.

Finally, number five, patient safety remains central. So, the FDA emphasizes the shift is not about relaxing standards, some may have perceptions that ISO 13485 audits are not as rigorous as FDA inspections. Certainly, these are coming together here and you can’t take any audit or inspection lightly. So, still very much about enhancing regulatory effectiveness while maintaining high standards for patient and user safety.

And this is it, tada, this is the QMSR, built that up for this slide. But on the left-hand side, you’ll see the QMSR, I’m sorry, the QS, the quality system regulation, QSR, so this is 820 as we know it and love it today. On the right-hand side, you’ll see a more abbreviated version, not to be perceived as a lighter lift. So, if you really start to dig into the details, the QMSR on the right, well, it’s smaller, it doesn’t look as scary, what you don’t see in any detail is section 820.7 which is incorporation by references so that is basically pointing to 13485 and ISO 9001 which contains terms and definitions but also 820.10 which contains a lot of the details, detailed requirements. So, there it is.

RELATED: Application of Risk Analysis Techniques in Jama Connect® to Satisfy ISO 14971

Keverline: Yeah. Under QMSR 820.10, so briefly mentioned that, it basically, again, points to the applicable requirements of ISO 13485:2016. QMSR 820.10(b) gets into additional requirements beyond ISO 13485; these are defined as unique device identification, which is more explicit than ISO clause 7.5.8. Medical device tracking which is applicable to implantables, so more explicit than ISO clause 7.5.81. Adverse event reporting, more explicit than ISO clause 8.2.3. And corrections removals, which ISO 13485 refers to as advisory notices, more explicit as it relates to clause 8.3.3. These don’t necessarily equate to new US requirements; rather, I’ll say, putting the hooks into ISO 13485 and, overall, the QMSR.

Certain existing QSI provisions will still remain in effect. For example, for lower risk devices, FDA has chosen to exempt some of those devices from design controls. So, that still remains in effect. Complaint and servicing records, device labeling and packaging requirements, these still stay in effect as well, they are really augmenting the 13485 as it relates to specific information that’s required on those records. And as it relates to labeling and packaging, FDA did not believe ISO 13485 covered these requirements fully and a lot of that’s based on labeling which is frequently associated with recalls, mislabeling, mix-ups, that kind of thing. So, they expanded on 13485 requirement here.

And because we like exceptions, so there’s some new definitions to the QMSR, you see that on the left. So, component, Federal Food, Drug and Cosmetic Act, finished device, HCT/Ps, and remanufacture. And on the right, these terms are different in the QMSR than what you’ll find in ISO 13485 or ISO 9001 so, again, this is the case where they would take precedence. Implantable medical device, manufacturer, organization, rework, safety, and performance.

While expectation by FDA is that you’re looking at risks in your processes and prioritizing accordingly, it’s not explicitly stated in the QSR for many processes; this is a big part of 13485. So, 13485 really emphasizes a process-based approach, risk management throughout the product cycle, more prescriptive supplier management, and proactive post-market surveillance. And these are really the key areas to watch if you don’t currently have 13485 in place and are moving forward with the QMSR, just a few areas that could be a heavy alert, for sure.

So, the exhortation for documented procedures, ISO requires more formal documentation and some legacy A20 systems. Risk-based decision making, this really needs to be embedded throughout your quality manual system, not just in product design. Supplier management, ISO requires evaluation, selection, monitoring and re-evaluation of suppliers based on risk. So, that adds a little more level of scrutiny than what’s currently in the QSR. And post-market surveillance, so ISO expects a proactive approach, not just reactive complaint healing. So, these are areas where we’ll be under scrutiny, for sure, as it relates to QMSR.

And here’s the timeline. So, final rule was published January 31st, 2024; there was a comment period prior to that, similar to the preamble. There’s some good stuff in there if you want to read some of the pushback. We’ll get to a couple of those later, but it’s a good read. There was a two-year transitional period; the QMSR becomes effective and enforceable February 2nd, 2025. Here we are, sitting in August 2025, so roughly six months away. If you’ve not started yet, you really need to get going, especially if you do not have ISO 13485 in your QMS today.

To Watch the Entire Webinar, Including An Info-Filled Q&A Session, Visit:
QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485

Extending End-to-End Traceability into the Semiconductor Design Cycle

Modern semiconductor design is a high-stakes, high-complexity endeavor. With fabless semiconductor companies evolving rapidly & tackling increasing design challenges, effective requirement traceability across the entire design lifecycle has never been more critical. Traditionally limited to the later stages of development, traceability now demands an upstream extension, covering Electronic Design Automation (EDA) and verification tools.

Why does this matter? Extending requirement traceability earlier into the semiconductor design cycle doesn’t just minimize errors; it ensures efficiency, reduces costs, and bolsters compliance. This whitepaper explores why integrating traceability into EDA tools benefits chip and system-on-chip (SOC) projects and how companies can set themselves up for success.

Why Extend Requirement Traceability to EDA Tools?

Manage Complexity Across Distributed Teams

Fabless semiconductor companies and Integrated Device Manufacturers (IDMs) increasingly rely on globally distributed teams and specialized domains for system, hardware, and software design. This decentralization makes collaboration more challenging, and critical requirements may get lost in translation.

Without clear traceability, common pain points include:

  • Miscommunication about design intent across teams
  • Misinterpretation of product requirements
  • Testing against outdated requirements
  • Uncertainty and risks in IP reuse, especially when lineage and design intent are undocumented

By extending the reach of traceability into EDA tools and workflows, organizations can create a direct link between system requirements, IP blocks, design intent, and test benches. This reduces the risk of potential miscommunication & ensures that every design artifact aligns with higher level business goals.

Identify Risks Early in the Design Cycle

Simulation and Verification capabilities in an EDA tool are critical checkpoints for ensuring alignment between architectural design and performance requirements. When connected to traceability frameworks, these tools elevate quality assurance and minimize risk.

Through such an integration, teams can:

  • Detect and correct inconsistencies in architecture, performance, and design constraints before tape-out
  • Proactively identify gaps in requirements coverage
  • Continuously monitor power, performance, and area (PPA) metrics as designs evolve
  • Increase chances of first silicon success

By tying simulations and verifications directly to requirements, companies preserve agility while safeguarding against expensive last-minute failures.

Lay the Foundation for Generative AI Integration

From defect prediction to automated generation of requirements and test cases, AI is transforming the semiconductor industry. To fully leverage AI’s potential, organizations need well-structured data from across their lifecycle that is traceable. This includes EDA tool and serves as fuel for AI-driven insights such as:

  • Defect predictions and design inconsistencies
  • Automated requirement creation and test case generation
  • Robust analytical capabilities with intelligent suggestions for coverage gaps and test improvement

This end-to-end integration is essential for companies aiming to improve the structure of their engineering data so it can be used as a data pipe to feed other AI/ML projects and initiatives.

RELATED: Join the Leaders Choosing Jama Connect® for Semiconductor

Avoid Failure Despite Mature Processes 

Even the most advanced requirements management processes can fail to bridge the gap between early design work and high-level product goals. This disconnect can result in overruns on cost and time while missing performance or functional
targets.

Without tightly linking decisions in early-stage EDA tools to requirements, organizations face:

  • Misaligned timing, throughput, or power targets during critical milestones
  • Slow root cause analysis when performance benchmarks are missed

Extending traceability ensures visibility into how each design decision affects product goals, enabling rapid adjustments and informed decision-making.

Facilitate Efficient Change Impact Analysis

Semiconductor design is an iterative process where late-stage requirement changes can ripple across RTL, DFT, and verification layers. Effective traceability enables teams to propagate changes efficiently and assess downstream impacts in real-time.

When EDA tool outputs, constraints, and simulations are part of the traceability chain:

  • Impact analysis for system requirement changes becomes seamless
  • Verification teams can identify affected test plans and test constraints instantly
  • Regulatory compliance processes become auditable and efficient

This end-to-end integration is essential for companies aiming to improve the structure of their engineering data so it can be used as a data pipe to feed other AI/ML projects and initiatives.

Ensure Regulatory Compliance and Certification

Whether it’s automotive (ISO 26262), aerospace (DO-254), or medical devices, safety-critical industries demand rigorous traceability and accountability.

By extending traceability into EDA ecosystems, semiconductor companies can provide proof of:

  • How requirements were implemented in RTL and verified through simulations
  • Continuous validation of system-level intents

This level of transparency is crucial for certification in highly regulated industries, ensuring customer and stakeholder confidence while avoiding compliance gaps.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Semiconductor

Practical Approach to Achieving End-to-End Traceability

Here’s how fabless semiconductor companies can implement a traceability framework that extends across the design, simulation, and verification layers.

System Layer: Where it All Begins

End-to-end traceability starts with a solid foundation at the system layer. This stage focuses on managing requirements and maintaining a clear connection between what the product must deliver and how those goals translate to system functions.

Key Takeaways:

  • Jama Software serves as the traceability hub to ensure alignment across teams
  • Model-Based Systems Engineering (MBSE) Tools such as Cameo enable detailed system modeling
  • Product Lifecycle Management (PLM) Tools like Windchill help track complete product lifecycles

Key Artifacts:

The artifacts at this stage include product requirements, architecture models, and functional and non-functional requirements such as PPA (power, performance, area) metrics.

Traceability Links:

High-level requirements are seamlessly linked to system functions and verification criteria, ensuring no gaps between product expectations and system capabilities.

Design Layer: Bridging Hardware and Software

Once system requirement baselines are established, the focus shifts to the design layer, where the intricate dance between hardware and software development takes place.

Key Tools and Resources:

  • RTL Design Software, like Synopsys VCS, simplifies design processes
  • Software Tools, such as Jira, streamline task management
  • Prototyping Tools, including Xilinx Vivado, assist with early-stage testing

Key Artifacts:

The main outputs here are HDL (Hardware Description Language) modules, design specifications for hardware and software, and integration plans to bring it all together.

Traceability Links:

At this stage, system requirements feed directly into design specs, which flow into HDL and software modules to uphold interconnected traceability.

Download the full whitepaper to learn more about the following topics:
  • EDA Toolchain Integration Layer: Simulations at the Core
  • Verification and Validation Layer: Testing the Foundation
  • Analytics and Decision Support Layer
  • Transforming Requirement Traceability with Jama Software
  • Set Up Your Semiconductor Design for Success

DOWNLOAD THE ENTIRE WHITEPAPER TO LEARN MORE:
Extending End-to-End Traceability into the Semiconductor Design Cycle

 

Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process Customer Story

Biofidelity chooses Jama Connect to enhance the process previously managed manually with Jira and documents.

Biofidelity, headquartered in Cambridge, United Kingdom, provides innovative technologies that unleash the potential of genomics for fast and accurate targeting and monitoring of cancer treatment.

Biofidelity was founded in 2019 with the goal of enabling millions of lives to be transformed through access to vital information needed for accurate targeting and monitoring of treatments for cancer and other illnesses. They develop innovative molecular technologies that remove the noise from genomic data to make analysis simpler, faster, and more adaptable. Healthcare providers, laboratories, patients, and biopharma firms rely on Biofidelity solutions to provide only the information needed to enable swift decision-making and ensure the best possible outcomes.

Biofidelity’s first product, Aspyre® Lung Reagents, is a research use only (RUO) product that enables simple, fast, and reliable detection of established biomarkers in tissue or blood for use in non-small cell lung cancer research. It includes the lab assay and turnkey cloud analysis software designed to be integrated into a customer’s laboratory. The company’s second product, Aspyre® Clinical Test for Lung, is a laboratory-developed test (LDT) that clinicians use to submit tissue or blood specimens to Biofidelity’s CAP-accredited, CLIA-certified lab for analysis with a quick two-day turnaround time from sample to result.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Challenges

  • No automated change control and review process for requirements and tests
  • Documentation preparation took seven to ten days every quarter
  • Needed to be ready to adapt to changes in regulatory environment

Biofidelity’s competitive edge is in developing products offering simplicity, speed, low failure rates, and sensitivity. As a startup beginning to scale, the company developed their products using a combination of general-purpose platforms, manually tracking requirements and tests, and checking traceability. Managing this information across several documents in separate systems required manual connections, leading to lack of formal traceability between tools. Additionally, while the team could view the history of changes and comments in Jira, there was no established process for reviewing and approving requirements. Significant effort was needed to correctly gather the approved content for release documentation.

For each quarterly product release, the company needed to ensure that all actions were complete and that all information was accurate. However, using Jira made it extremely challenging to consolidate and display all the requirements, test items, and their upstream and downstream relationships. Jira only provided a basic draft table of user needs for verification and left the validation process to be handled manually using a spreadsheet.

The resulting process of generating documents took seven to ten days each quarter. “When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming,” said Adam French, Associate Director of Software & IT, Biofidelity.

Although mandatory FDA oversight of LDTs were originally slated for 2025, Biofidelity demonstrated foresight by recognizing the need to stay ahead of the evolving regulatory landscape. They took proactive steps to improve their product development processes to ensure they could demonstrate compliance.

The need for better processes was driven by the company’s aim to make Aspyre technology accessible to millions of people affected by cancer each year, which requires the ability to adapt to new target markets more
quickly and easily.

When we were developing a release, we spent a lot of time creating a traceability matrix by hand in Excel. Trying to connect all the requirements and test item types that were separate in Jira was hugely time consuming. – Adam French, Associate Director of Software & IT at Biofidelity

RELATED: Jama Connect Features in Five: SaMD Framework

Evaluation

  • Alignment of requirements with Jira issues
  • Automation of requirements and tests change control
  • Process for reviewing and approving requirements
  • Faster generation of documentation

The company initially set out to find a test management system. However, they quickly discovered that general-purpose project management software, even with plugins, lacked features for requirements management, collaboration, and traceability. In searching for application lifecycle management systems for medical device development, they found Jama Connect, MatrixALM, and Visure Requirements.

After an evaluation involving the software development team, Jama Connect was chosen for its superior configuration, control, and review of changes, and documentation capabilities. Jama Connect and its Software as a Medical Device (SaMD) framework offered flexibility and a depth of configuration that included templates and pre-configured out-of-the-box item types that closely aligned with the team’s existing Jira issues.

The team valued how Jama Connect offers efficient and reliable control over changes to requirements and tests through traceability. In Jama Connect, impact analysis identifies all upstream and downstream traced items affected by a change. Additionally, suspect links are automatically created after changes are made to designated fields, flagging all downstream requirements that may no longer be accurate, complete, or verified.

“Adding control of changes and relations between all item types was the most important thing for us. You can put relationships between Jira issues, but it doesn’t give you the suspect link notification, review process, or control to check upstream and downstream items after you change a source item,” said Max Artomenko, Software Engineer, Biofidelity.

Aside from the Jama Connect product, there were two other reasons for the choice. The Jama Software team spent a significant amount of time answering and asking questions that went to the heart of what the Biofidelity team needed. In addition, a member of the software development team had previous practical experience of how Jama Connect could be effectively integrated into the software development process.

RELATED: QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485

Outcomes

  • Reduced documentation preparation time by 33 – 50%
  • Increased standardization and automation of requirements change control
  • Development process that’s ready for dynamic regulatory
  • Ability to expand into risk analysis and additional teams, products, and markets

With Jama Connect, Biofidelity has reduced documentation preparation time for each release from seven to ten days down to two to three days, a 33-50% reduction. More importantly than the time savings, the team remains confident that the information is correct and ready for FDA audits due to the automated traceability, suspect link notifications, and review processes in Jama Connect.

Jama Connect has standardized how and where all the different teams create and store content. That helps ensure the team is alerted when changes are made and manage changes to team makeup. “Most important for the company is to have one source of truth for all user needs relating to software and hardware requirements, even when the teams change,” said Artomenko.

Unlike in the past, the team can do its traceability analysis in Jama Connect at any moment, even during development. This provides greater control of changes that affect the state of software requirements.

The company successfully transitioned their issue types from Jira into Jama Connect item types and experienced improvements in managing them. The plan is to further expand the management of requirements and tests in Jama Connect by incorporating risk management using the FMEA item type, which is readily available in Jama Connect’s SaMD framework.

By shifting risk analysis from Excel to Jama Connect, the team anticipates gaining more efficient control over risks, including immediate ways to demonstrate that all risk items have mitigations that are implemented and tested.

While the software team was the first to use Jama Connect, additional R&D teams are evaluating Jama Connect to potentially manage their user needs, requirements, and tests for other related products. Jama Connect’s support for reuse of existing requirements and tests could translate into faster development of new products and entry into new markets. “One of the key advantages of Jama Connect is that it improves our processes and makes it easier for us to move into new markets and adapt as regulations change,” said French.

“As we move into a regulated space in the future, we expect to be audited more frequently. With the help of Jama Connect’s SaMD framework, we are getting ready to be able to demonstrate that the quality is there every time.” – Adam French, Associate Director of Software & IT at Biofidelity

DOWNLOAD THE ENTIRE CUSTOMER STORY HERE:
Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process

From AI to Roadmaps: Your Guide to Jama Software’s Upcoming Community Events

In this blog, we share exciting upcoming Jama Software Community Events!

From AI to Roadmaps: Your Guide to Jama Software’s Upcoming Community Events

Are you ready to connect, learn, and grow with a community of like-minded professionals?

Jama Software Community Events are here to empower our customers with insights, strategies, and tools to maximize your success with Jama Connect®.

Whether you’re tackling challenges in requirements traceability, regulatory compliance, or product and systems development, these events are your gateway to meaningful conversations and actionable solutions.

Please note: These events are for existing customers only. If you are not currently a customer and would like to start a free 30-day trial, click here!

Here’s a sneak peek at the exciting lineup of upcoming events:

1. Explore Customer Success Journeys

Date: August 27, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Discover how tailored support solutions can align with your business goals. Learn about Premium, Strategic, and Essentials Support Plans, and gain practical strategies to enhance efficiency and ROI. Don’t miss this opportunity to elevate your experience with Jama Software.

Register Now!

2. Ask Me Anything (AMA) with our VP of Solutions & Support

Date: September 24, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Get exclusive insights from Jama Software’s VP of Solutions & Support, Preston Mitchell. Learn time-saving strategies, actionable tips, and answers to your burning questions in this interactive session.

Register Now!

3. The Future of Requirements Management with AI

Date: October 15, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Join Senior Product Manager Katie Huckett to explore how AI is revolutionizing requirements management and product development. Gain insights into AI-driven tools that enhance clarity, precision, and collaboration.

Register Now!

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

4. Product Roadmap Session

Date: November 5, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Be the first to learn about Jama Software’s upcoming features and enhancements. This session offers a glimpse into the future of innovation and how it can empower your workflows.

Register Now!

5. Reflect on Jama Connect’s Top Features of 2025

Date: December 3, 2025 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Take a look back at the standout features of Jama Connect in 2025. Learn how these innovations have driven efficiency and collaboration and discover how to maximize their impact in your organization.

Register Now!

6. Lean Coffee with Jama Software

Date: January 22, 2026 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Kick off 2026 with an interactive Lean Coffee session. Collaborate with experts and peers to tackle challenges in product, systems, and software development.

Register Now!

7. Fireside Chat with Jama Software

Date: February 10, 2026 | Time: 8:00 a.m. PT / 5:00 p.m. CEST
Engage in a conversation with a leading Jama Software executive. Get firsthand insights into the latest updates, upcoming developments, and strategies to drive impactful results.

Register Now!

RELATED: Jama Connect Continues to Dominate as the #1 Leader in Requirements Management Software

Why Attend?

  • Learn from Experts: Gain actionable insights from industry leaders and Jama Software experts.
  • Collaborate with Peers: Exchange ideas and strategies with power users.
  • Stay Ahead: Discover the latest innovations and trends shaping the future of product development.

Don’t miss these opportunities to connect, learn, and grow. Reserve your spot today and take the first step toward transforming your potential into action.

CLICK HERE: Explore All Events and Register Now!

Graduation clock drawing next to a "watch now" button and the headshot of the speaker on this topic about nuclear reactor design.

This blog recaps our recent Features in Five video on the topic of Jama Connect’s out-of-the-box nuclear reactor design and I&C development solution.

Jama Connect® Features in Five: Nuclear Reactor Design and I&C Development Solution

Learn how you can supercharge your systems development process! We always want to be respectful of your valuable time. Still, in this Features in Five video, we do go beyond the promised five-minute format to include an information-packed session, hosted by Vlad Tanasescu, GM, Industrial & Consumer Electronics, Jama Software.

Designing nuclear reactors is a complex, high-stakes process requiring precision, safety, and collaboration. Jama Connect’s out-of-the-box framework simplifies this complexity by guiding engineering teams through requirement decomposition, safety assessments, and risk analysis while ensuring traceability across the entire digital thread.

With AI-driven automation, real-time gap detection, and seamless tool integrations, Jama Connect empowers teams to streamline processes, enhance collaboration, and accelerate time to market, all while maintaining the highest safety and compliance standards.

VIDEO TRANSCRIPT

Vlad Tanasescu: Hi, I am Vlad. I lead our energy business unit here at Jama Software, and today I will walk you through a brief live demonstration of our new out-of-the-box nuclear reactor design and instrumentation and control (I&C) system development framework. Our engineering management platform, Jama Connect, enables an intelligent, guided, and measurable product development approach. In Jama Connect, we use process rules to define end-to-end engineering and design processes. Jama Connect will leverage this process to automatically guide the engineering organization through their development, intelligently measure system and process completion, and automatically detect gaps and risks so that engineers know where to take action.

On a high level, our nuclear reactor design framework starts from the decomposition of the requirements and the parallel decomposition of our designs and architectures from the highest level of the plant all the way to the mechanical and software implementations. The framework natively enables the initial deterministic safety assessment, the classification of initiating events in design-based accidents, the categorization of security and safety functions, and the classification of structures, systems, and components in alignment with the guidance of the International Atomic Energy Agency (IAEA) and local nuclear reactor design assessors.

The framework also includes the probabilistic safety assessment, the accident, and those consequence analysis and the analysis of combined risks. Nuclear reactor design is highly iterative. As our design and construction progresses, we will continuously find new safety and security requirements and functions as well as new reliability requirements and special treatments, all of which will need to cascade and feedback into the functional and non-functional levels of our reactor. Nuclear reactor design practitioners integrate model-based systems engineering, product life cycle management, pipeline and instrumentation diagramming and software development tools to Jama Connect to extend the traceability from the definition of our reactor to how our reactor is being implemented in mechanical software and electronics disciplines.

RELATED: Power Efficiency and Innovation Across Your Development Process with Jama Connect for Energy Storage Systems

Tanasescu: These integrations will enable us to programmatically measure traceability and system completion across all of our tools, part of the engineering digital thread. For example, from one of our high-level mission needs, energy efficiency, we can directly visualize the allocation to a plant design coming from a model-based systems engineering solution, and then we can follow the decomposition of the requirement and the plan design all the way down to the mechanical implementation.

For example, from this plan design, we have derived multiple system architectures of the key reactor systems, which are further decomposed into multiple subsystem designs, which are further decomposed into component designs, which are ultimately decomposed into mechanical implementations like parts and key assemblies. This end-to-end traceability across the entire digital thread will enable us to understand the impact of changes starting from a requirement all the way down to the lowest implementation level. For example, if I were to change this energy efficiency requirement, I could run an impact analysis in Jama Connect, and then Jama Connect would show me that multiple design levels would be impacted by the change, but five levels down, I would also be impacting implementations in mechanical parts. I would be impacting safety mitigations and risk mitigations as well as executed tests, which is very powerful to understand before the change.

Jama Connect will use intelligent engineer management features like the Live Trace Explorer to intelligently measure the completion of our traceability across the entire digital thread. These intelligent measurements will programmatically summarize the completion of the decomposition of the requirements, the decomposition of the designs, the test coverage, the risk mitigations, as well as the completion of the implementation of our system. Due to the integrations with other tools like product lifecycle management or model-based systems engineering applications, we can start measuring to what extent our component designs have been implemented in parts or our software requirements in software implementations. For example, here we can see that only 2% of our component designs have been implemented in parts or only 2% of our component designs have been analyzed and taken into account in the initial deterministic safety assessment. These intelligent measurements will enable companies to mitigate, rework and reduce their time to market. We will always be able to understand where we have gaps and risks in our system so that we know where to take action.

RELATED: Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect for Nuclear Reactor Design & I&C Development

Tanasescu: In Jama Connect, we use the project tree to visualize and access all of our engineering data in one view. The project tree will also enable us to set up our product breakdown and systems engineering structure. Here, we can see the key subsystem of the reactor and the balance of plant, each subsystem having its respective requirements, designs, and tests, and then one level down, we can visualize the key components of our subsystem. Each component, including requirements, designs, tests, and mechanical software, electronic specific implementations like parts or software user stories. Our out-of-the-box nuclear reactor design framework also contains data models for the automatic calculations and classifications of initiating events and design-based accidents for the categorization of safety and security functions and for the classifications of structure systems and components. The Jama Connect Nuclear Reactor Design framework will also enable the automatic export of initial, preliminary, and final design safety reports and will enable the programmatic creation of security and safety cases.

Our I&C system development framework is reduced to the scope of the development of nuclear reactor subsystems. And in accordance with standards like EEC or EEC61508, the I&C development decomposition starts at the level of the safety design base. The I&C systems development framework also enables codevelopment. Nuclear reactor OEMs, I&C system T1s, and external engineering partners can use Jama Connect as a central source of truth for the entire design and engineering-related collaboration, and they can use Jama Connect’s intelligent engineering management capabilities to measure system completion and identify gaps across the entire engineering data coming from all the partners from our development ecosystem.

We view the adoption of artificial intelligence as essential for reducing time-to-market and increasing efficiency in nuclear development. Jama Connect’s engineering AI enables engineers to highly automate day-to-day and manual tasks like the definitions of tests or the decomposition of requirements. For example, here I have a requirement related to the nuclear fuel and instead of me deriving the test manually, I will use Jama Connect’s engineering AI to derive multiple tests automatically*, and then Jama Connect’s AI will proceed to derive multiple tests that our engineers could choose to take over and relate in traceability with the requirement.

This way, both the test generation and the traceability creation will be highly automated. Thank you very much for your time. If you want to learn more about our nuclear reactor design and IC system development framework, please visit our website. Thank you.

*Test Case Generation available through our add-on product, Jama Connect Advisor™

To view more Jama Connect Features in Five topics, visit:
Jama Connect Features in Five Video Series

Jama Connect Best-in-Class API for Creating Interoperability Across Your Development Toolchain for Live Traceability™

Siloed data creates significant roadblocks for businesses. Isolated information across teams and systems obstructs collaboration and slows critical decision-making. Open APIs provide a solution to this problem by enabling interoperability between compliant software.

Jama Connect features a best-in-class REST API for connecting to any other REST-compliant software or system. Our API is the basis of the many prebuilt integrations available from Jama Software & our partners.

What makes Jama Connect API the best- in-class

  • Accessible: Anyone with a Creator license can utilize the REST API – at no additional cost and no charges based on number of API calls.
  • Performant: Each Jama Connect Cloud instance allows up to 36,000 calls per hour/over 26 million calls per month, significantly more than other large SaaS providers.
  • Reliable: Industry standard best practices, such as API throttling, maintain system stability for consistent and reliable performance with minimal latency.
  • Comprehensive: We provide documentation accessible through Swagger UI, code snippet examples, and training from Jama Software’s services team who are experts in using the API.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

KEY BENEFITS

  • Streamline Integration Processes: Combine Jama Connect API’s simple, flexible, and easy to use framework with the API cookbook, a step-by-step guide with practical, real-world recipes that address common integration needs, offer clear best practices, and answer frequently asked questions.
  • Boost Data Handling Efficiency: Manage data seamlessly with advanced features like strict pagination and the ‘include’ parameter. These optimizations
    ensure your API calls retrieve only what you need, reducing system strain and enhancing performance during data-intensive operations.
  • Leverage Strict Security and Authentication: Prioritize security with OAuth authentication for Jama Connect Cloud users or Basic Authentication for self-hosted environments. Jama Connect API ensures the integrity and safety of your data during every integration.

Using the Jama Connect API

There are many ways to benefit from the Jama Connect API. Here are several examples:

  • Reporting: Automate the retrieval of project data for reporting purposes. By making GET requests to the API’s/projects endpoint, users can fetch detailed information about all projects within their Jama Connect instance. This data can then be integrated into business intelligence tools for real-time tracking of project progress, resource allocation, and key milestones.
  • Data & Trace Synchronization: Automate the synchronization of requirements and their trace relationships between Jama Connect and other REST-based tools for Live TraceabilityTM. This can be particularly useful for organizations that need to ensure alignment between their requirements management system and their development tracking tools. By leveraging the API, users can create scripts to push updated requirements and their traces from Jama Connect into their development platform or pull issue statuses back into Jama Connect.
  • Test Results Import: Automate the import of test results into Jama Connect. This ensures precise control, real-time updates, and integration with third-party test tools and related workflows for more efficient and reliable verification of new and changes to requirements.

RELATED: Requirements Traceability Benchmark

Jama Connect API Resources:

Whether you’re retrieving actionable insights, integrating data across tools, or optimizing test workflows, Jama Connect API empowers your business with flexibility and performance.

Get started with the Jama Connect API today!

DOWNLOAD THIS DATASHEET:
Jama Connect Best-in-Class API for Creating Interoperability Across Your Development Toolchain for Live Traceability™

Bridging ALM and MBSE for Modernized Systems Engineering Practices

This blog recaps our recent Whitepaper, to download the entire thing, visit “Bridging ALM and MBSE for Modernized Systems Engineering Practices.”

Bridging ALM and MBSE for Modernized Systems Engineering Practices

1: Introduction

In an era marked by rapid advancements in technology, the aerospace and defense industries face increasing complexity in systems engineering. Addressing these challenges requires a paradigm shift towards more integrated and collaborative workflows. This whitepaper explores the essential relationship between Application Lifecycle Management (ALM) and Model-Based Systems Engineering (MBSE), highlighting how bridging these disciplines can modernize systems engineering practices.

2: The Growing Complexity of Systems Engineering

The complexity of systems engineering has grown exponentially in recent years, driven by advancements in technology, globalization, and the increasing interconnectivity of systems. Modern systems often integrate a wide array of specialized components, from hardware to software, all of which must seamlessly function as a whole. This challenge is further compounded by the need for performance optimization, cybersecurity considerations, and adherence to regulatory and safety standards, which vary across industries and regions.

For example, in the aerospace sector, the development of next-generation aircraft requires the integration of advanced avionics, autonomous systems, and material innovations. These aircraft must not only meet stringent performance criteria but also comply with international safety regulations and environmental standards. Similarly, in the defense industry, modern weapon systems rely heavily on interoperability between software-driven subsystems, such as sensors, communication networks, and artificial intelligence algorithms, all of which must operate flawlessly in highly dynamic environments.

To manage this complexity effectively, systems engineers must adopt integrated methodologies that bridge gaps between disciplines and stakeholders. Traditional linear workflows and siloed engineering practices can no longer keep pace with the demands of today’s systems. The introduction of tools and frameworks like MBSE enables teams to visualize and validate system designs in a digital environment, ensuring all components meet specifications before physical prototypes are developed. Combined with ALM, MBSE enhances traceability and communication, fostering collaboration across various teams and ensuring that every aspect of the system remains aligned with the overall mission objectives.

By leveraging integrated approaches and modern engineering tools, organizations can address the escalating challenges of systems complexity, enabling them to deliver innovative solutions while minimizing risk and maintaining efficiency.

The demand for innovative, safe, and efficient systems in aerospace and defense has led to unprecedented levels of complexity. Systems engineering processes need to manage a significant volume of requirements, design models, stakeholder expectations, and compliance standards. Traditional engineering approaches fall short of addressing these demands effectively, creating the need for solutions that promote end-to-end traceability and model-driven development.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

3: ALM and MBSE Defined

3.1 What is ALM?

Application Lifecycle Management (ALM) is the framework that encompasses the entire lifecycle of a system, from concept and design to implementation, testing, and maintenance. ALM ensures alignment between business needs, development efforts, and operational goals.

3.2 What is MBSE?

Model-Based Systems Engineering (MBSE) represents a paradigm shift by focusing on the use of models as the primary means to design, analyze, and validate system behavior. MBSE emphasizes simulation, system-wide visualization, and clear documentation to foster collaboration and problem-solving.

4. The Value of Integration

Integrating ALM and MBSE enhances engineering by enabling a seamless flow of information and fostering cross-disciplinary collaboration. This integration is fundamental to achieving traceability between requirements, design, and verification, ensuring that projects meet critical objectives efficiently.

4.1 Improved Traceability

By linking tools like Jama Connect with system modeling tools, teams can create a direct trace from system requirements, design decisions, test cases, and compliance reports to the system model analyses, parameters, and behaviors. This level of traceability minimizes risks and helps ensure that the final product aligns with initial specifications.

4.2 Enhanced Collaboration

Bridging ALM and MBSE facilitates better communication among stakeholders by providing shared insights and clear documentation of system behaviors. This reduces misunderstandings and promotes alignment across all project phases.

4.3 Accelerated Development Cycles

Integrated workflows reduce redundancies, streamline handoffs, and eliminate rework, allowing engineering teams to accelerate system development while maintaining high quality and compliance standards.

RELATED: Compliant Engineering: Leveraging Live Traceability for Regulatory and Product Compliance Success

5. Tools to Enable ALM and MBSE Integration

Jama Connect for MBSE

Jama Connect is a powerful tool that brings cohesiveness to Model-Based Systems Engineering by enabling efficient requirements management, traceability, and collaboration throughout the system lifecycle. By integrating with MBSE processes, Jama Connect provides a centralized platform where teams can define, manage, and validate requirements while ensuring alignment with system models. Through its robust traceability features, Jama Connect ensures that every requirement is linked to design elements, testing artifacts, and verification processes, creating a comprehensive digital thread.

One of the key strengths of Jama Connect is its ability to foster collaboration among diverse stakeholders. The platform offers an intuitive interface for real-time communication, enabling engineers, project managers, and business teams to work together seamlessly, ensuring clarity and reducing the risk of misunderstandings. Additionally, Jama Connect’s alignment with compliance standards streamlines audits and regulatory reviews, essential for industries with rigorous certification requirements.

When linking Jama Connect with system modeling tools, such as SysML modeling solutions, Jama Connect facilitates continuous synchronization between system requirements and system architecture models. This reduces errors, eliminates redundancies, and supports iterative development, helping teams adapt to changes quickly. Ultimately, Jama Connect empowers organizations to align engineering objectives with business goals, ensuring that the end product meets customer needs and system specifications efficiently.

LemonTree.Connect™ for Enterprise Architecture

LemonTree.Connect™ acts as a bridge between ALM and MBSE tools, offering advanced capabilities for merging and synchronizing data to maintain consistency across systems models and requirements.

When used together, Jama Connect and LemonTree.Connect™ create a unified environment for modern engineering practices.

TO READ PARTS 6 – 10, VISIT:
Bridging ALM and MBSE for Modernized Systems Engineering Practices

Black and white image of the host of this webinar, against text reading the topic as building efficient and effective product development.

This blog recaps a preview of our webinar, “Building an Efficient and Effective Product Development Process” – Click HERE to watch the entire video.

Building an Efficient and Effective Product Development Process

Managing shifting priorities, complex requirements, and compliance across teams is no easy task. But optimizing your workflows could make the difference between staying competitive and falling behind.

Join Patrick Knowles, Senior Solutions Consultant at Jama Software, for this 45 minute webinar to learn how to build more efficient and effective product development processes — and avoid the preventable setbacks caused by outdated workflows.

What you’ll gain:

  • Understand how ineffective requirements processes lead to costly delays
  • Discover strategies to accelerate development with structured, fine-grained data
  • Improve visibility and collaboration to address risks early
  • Learn how dynamic workflows replace outdated, linear processes for greater success

Whether you’re tackling recurring challenges or looking to refine your team’s processes, this session will provide practical solutions backed by industry insights and real-world success.

Patrick Knowles: Hello everyone. My name is Patrick Knowles and I come from a background of systems engineering across the aerospace and defense industry in both defense and commercial space. During my time in industry, I was a Systems Engineer, Lead Systems Engineer, and Systems Engineering Manager, where I’ve been privileged to see multiple different product development processes and life cycles.

Today I want to share my experience in industry and marry that with how Jama Connect can help each of your teams be empowered to effectively improve and develop products. During today’s webinar, I will share the key challenges of developing complex products and how Jama Connect can help alleviate these pain points. This will include how collaboration can mitigate issues, teams face, how compliance to standards and regulations can be simplified, and how to accelerate the final portion of product development, V&V.

What we’re hearing from customers is that they need to move faster, that their products are becoming more complex, and integration of the engineered products as well as within teams is becoming increasingly common. In engineering, we like to go fast. We like to run first and fail early, none of which is inherently bad. However, when teams are unprepared for the inevitable mistake or misstep, things can fall off the rails pretty quickly.

RELATED: The Strategic Transition: From Word and Excel to Modern Requirements Management

Knowles: Teams that are pushing to keep on schedule, sometimes miss standards, regulations, or even properly validating their product. Many times these things that teams lose track of, they lose track of their documentation that will be critical to the field when they go to field that product. Things get lost in emails, Slack channels, teams chats or worse, on someone’s hard drive that gets left out in the rain, of course, that would be the nightmare scenario.

Moving fast is probably the root of many of these issues, but it can be prevented by teams doing some other things that don’t inherently slow them down. As we progress throughout today’s webinar, my hope and what I’m trying to get across here is that it becomes incredibly clear that we want to enable your teams to run at full speed from the get go here at Jama. The pressure of speed is of course not the only challenge teams face though. The products that we develop nowadays are becoming more and more complex, right? If we think about just the evolution of a calculator, or a cell phone, or a computer over the last 20 years. Everything is getting smaller, tighter, better form, better fit, better function, but that also increases the complexity.

So when all the parts are moving, all the data is spread across a plethora of channels and teams are pushed to develop to the next generation of the greatest gadget. These increased complexities lead to preventable failures becoming unfortunately more routine, but we are going to discuss some of the ways to treat that as we go forward here.

Creating a thread of data that can be traced from the top to bottom is one of those ways in which Jama Connect can support a team facing these issues. In fact, starting simple in Jama Connect can help a team develop their complex products more efficiently. But as you will see later in this presentation, start simple does not mean you must maintain that simple starting point. In fact, we actually really want to talk about how you evolve and optimize as you go forward. That’s really the main theme that you’re going to see throughout this presentation.

RELATED: Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense

Knowles: Finally, integration between teams and products is becoming more and more challenging, particularly in the end stages of development. Teams are typically fantastic at creating things and talking together while they’re creating them, but when it comes to properly confirming that they created the right thing in the right way, we see a lot of unforced errors, to use a sports term, that typically is due to a lack of centralized stream of consciousness. Where all the thoughts, all the design energy goes into the same centralized location. This, of course does not to be the case, and in fact, we’ll spend a good portion of today’s session discussing collaboration and efficient centralization of information.

So how do we improve development processes, especially when we’re talking about collaboration? I want to dig into that topic here to help illuminate how to engage with some of the best practices in Jama Connect, as well as why these approaches are suggested.

One of the worst things in the digital age is trying to find something. You want to find that document, you can’t, but I actually believe that the next worst thing, or maybe even worse, is when you find the information and you simply can’t understand its intention, why it was written the way it was, and you’re trying to decipher why the decision was the way that it is, why the requirement exists or generally why something really came to be in the way that it is today. So let’s pretend you’re a bright-eyed and bushy-tailed new engineer developing something like a next-generation munition for cutting-edge, new fighter jet.

The team you are on has been tasked with taking a legacy design, 25 years of work, and revamping it for the modern age, using more sophisticated components and integrating whatever else it might be there. You show up day one of this effort and begin to realize all the legacy design was completed 25 plus years ago. There are a few Holy Grail documents that really guided the design, but much of the system was developed before teams that adopted data-centric tools like Jama Connect. So you sift through mountains of paperwork to determine why the system was designed the way it was, and that’s not inherently all that easy to do. It’s time staking, it is difficult to get the right information out.

Now imagine 25 years in the future still you, still same person. You are now leading the charge of another new development, same scenario, new fighter jet, new munition, but now it’s another new fighter jet, another new munition. This time you sit down on day one and you log into Jama Connect filled with itemized requirements, regulations, interfaces, and other information that has comments and commentary like you see here on the right side of the screen from engineers who develop stuff and you see the call and the response between them and their teammates. You can filter on all this information. You can search for key topics. You can start from either one single item or sort through all of the information and commentary in the database.

In this example, I think it’s easy to see the difference first hand of how centralizing communication can support long-term wins.

To Watch the Entire Webinar, Visit:
Building an Efficient and Effective Product Development Process

Jama Connect® Continues to Dominate as the #1 Leader in Requirements Management Software

Jama Connect® Continues to Dominate as the #1 Leader in Requirements Management Software

We’re proud to share that Jama Connect has once again proven its excellence, securing the #1 spot in G2’s Summer 2025 Grid® Report for Requirements Management Software! This marks the sixth consecutive quarter that we’ve been named the overall leader, solidifying our position as the go-to solution for teams managing complex product and software development lifecycles.

This recognition, driven by the feedback and trust of our users, continues to place Jama Connect ahead of competitors like Polarion, IBM® DOORS®, and Codebeamer. It’s a testament to our commitment to innovation and customer satisfaction.

Click here to explore the full G2 Summer 2025 Grid Report for Requirements Management Software!

Why G2 Recognition Matters

G2’s Grid Reports rank software solutions based on real user reviews, data from online sources, and analysis via G2’s proprietary algorithm. With this rigorous evaluation, the Summer 2025 report highlights the industry’s top performers, and Jama Connect leads the pack yet again.

For this quarter, Jama Connect achieved a customer satisfaction score of 97, accompanied by over 150 unique reviews praising our ease of use, unmatched collaboration features, and ability to streamline traceability across projects.

RELATED: The Essential Guide to Requirements Management and Traceability

Excelling Across All Categories

This quarter, Jama Connect didn’t just hold onto its top spot — we earned recognition across a wide array of categories. Here’s a breakdown of the accolades we garnered in the G2 Summer 2025 report:

    • Overall Leader
    • Momentum Leader
    • Small-Business Leader
    • Mid-Market Leader
    • Enterprise Leader
    • EMEA Leader
    • Europe Leader

These achievements underscore the versatility and scalability of Jama Connect, making it an ideal choice for teams of any size, across multiple industries and regions.

What Our Users Are Saying

We owe this success to the valuable insights shared by our customers, whose feedback drives us forward. Here are just a few highlights from recent G2 reviews:

“Jama Connect provides the end-to-end traceability that is expected in the Healthcare industry” – Harold M, R&D Engineering Manager

“Jama Connect is extremely intuitive. Team members are able to use it immediately without any prior training. We do have a training program that is recommended for the entire team but that serves to show everyone how to take the best out of the tool.” – Alexandre, Systems Engineer, Mid-Market

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

Modernizing Requirements Management

This recognition bolsters our mission to help organizations transition from outdated document-based processes to a modern requirements management platform. With Jama Connect, teams can achieve:

  • Enhanced clarity and accountability through real-time collaboration
  • Seamless traceability to manage requirements, risks, and test cases
  • Compliance with industry-specific regulations and standards

Our continued focus on innovation ensures that we meet the evolving needs of organizations navigating increasing product complexity and regulatory demand.

A Heartfelt Thank You

This milestone is not just our achievement but a shared success with our users. Your trust and feedback inspire us to deliver outstanding solutions that simplify your workflows and enhance your product lifecycle management.

Thank you for being part of this incredible journey. Rest assured, we’re committed to pushing the boundaries of what’s possible with requirements management.

Learn More

To see how Jama Connect stacks up, explore the full G2 Summer 2025 Grid Report for Requirements Management Software.

Thank you for choosing Jama Connect as your partner in solving complex challenges! Here’s to continuing this legacy of excellence together!

The semiconductor industry is evolving rapidly, with growing challenges in managing System-on-Chip (SoC) complexity and expanding Intellectual Property (IP) portfolios. How can your team stay ahead while maintaining efficiency and collaboration?

In this webinar, Steve Rush, Principal Solutions Consultant at Jama Software, discussed how Electronic Design Automation (EDA) organizations can adopt a more integrated and controlled approach to IP and SoC management using Jama Connect®.

This webinar provides key insights and practical guidance, including how to:

  • Overcome critical challenges in scaling SoC design and managing growing IP portfolios
  • Implement more integrated and efficient workflows using Jama Connect
  • Achieve measurable improvements in collaboration, scalability, and development outcomes

Steve Rush: It’s a pleasure to be here today to talk to you about this subject. I’ve worked with many customers and prospects across many different verticals, and semiconductor is certainly a vertical that has its own unique set of challenges. This subject is kind of near and dear to a lot of the conversations that I’ve been having, so I really hope that you find this insightful.

In this webinar, we’ll address some of the challenges that many semiconductor design companies are facing when kicking off SoC projects, leveraging the IP that they’ve already developed. Hopefully the audience out there finds this timely and relevant. We’ll level set a bit on the challenge itself, and then discuss three strategies for scaling SoC projects, along with product administrations to support each strategy, and then we’ll wrap up with some Q&A.

First, let’s start with some definitions: IPs and SoCs, what are they? What do we mean? IP cores, sometimes called IP blocks or foundational elements for systems on chip design. They’re really modular building blocks that are designed and purpose-built, and can be compiled to develop an SoC. An SoC, the system-on-chip, is an integrated circuit that comprises all of the system components onto one piece of silicon, which is made up of different IPs.

Our SoC here contains a processor core, a memory IP network on chip, and then multiple IPs themselves, which in and of themselves might be considered projects. When we zoom in to a particular IP, you can see the multiple components of that IP: the microcontroller that acts as the brain of the IP, designed to perform specific tasks and hold processing instructions. The ROM and SRAM, read-only memory and static access memory, are the internal communication fabric, the on-chip network, controlling multiple components, interrupts, controlling electrical current flow, the IO interface, and the input-output interface, which allows IP to communicate to the outside world.

You might be managing this information in a Jama Connect project for an IP core, multiple projects for multiple IP cores, or even multiple versions of those IP cores, depending on your version management strategy. Now that we’ve level-set a bit, let’s move on to some relatable challenges that you might have found yourself in. As semiconductor companies scale, individual IP projects need to be combined onto a single piece of silicon, these SoCs. As we saw in the last slide, different IPs may need to be combined to compile and build that SoC.

Organizing and tracking which IP, and importantly which versions of those IPs, which might be scattered across multiple repositories following different processes, can be daunting. You can imagine if you’re not using a system like Jama Connect, that might require a lot of manual effort, a lot of copy and paste, a lot of data reentry, and that can feel chaotic. For folks out there that are not using Jama Connect or just don’t have a well-defined process in Jama Connect, you might be relying on a lot of institutional knowledge when the time comes to compile these different IPs to build your SoC.

RELATED: Extending End to End Traceability into the Semiconductor Design Cycle

Rush: Maybe your lead engineer knows which versions of the IPs you need to use, or what third-party software licenses you need to monitor and update, but it’s just not well-documented. You don’t really have a system in place to manage all of this. If someone walks out the door, a lot of that knowledge walks out the door as well. Of course, you do what you can to capture that knowledge, and do a knowledge transfer, but it’s still just a very fragile system that you’re relying on.

Maybe you do have some semblance of a system, but it lacks consistency and unification. The IP core requirements are maintained in different systems, maybe different requirement management repositories. Maybe they’re just documented on Wikis, like Confluence, which comes to mind, but there’s no unifying data model. Without that, this creates traceability risk when you recompile everything to build your SoC project. How can you be sure that you’re completely covered and you have no traceability gaps?

Now, I’m not advocating that everyone has to follow the exact same process down to the T. Some level of autonomy might be necessary for different teams managing different SoC projects, and that is necessary, but there should be some unifying model and some unifying process that teams can follow to address these different gaps and risks. Here’s a slide that might resonate with you all. The current challenges you might be facing, the impact of those challenges, the goals, and business outcomes are all sort of documented here.

This represents a cross-section of a lot of customers and prospects that I’ve been talking to in the semiconductor design industry. The strategies that I’ll discuss and impart today speak to both of those personas: a prospect that’s not using Jama Connect or an existing Jama Connect, that just needs to scale up and optimize their use of Jama. Let’s look and talk about some of these challenges. Customers need to scale SoC management on Jama Connect.

Scale, that can be a vague and overused term, but what I think about when I hear this is that customers are really looking for control, a plan, and a tool with the right functionality to help them manage this complexity. Versions of IPs are scattered across multiple projects or systems. A couple things come into mind right away here: that immediate clarity when it comes to either applying a change, or resolving a defect, or figuring out what third-party software is being used for which project or product, it just is impossible.

RELATED: Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development

Rush: Future projects are coming down the pike, requiring reusing out-of-context IPs for in-context SoC projects, possibly needing to maintain both the out-of-context IPs and then the new in-context IPs, which make up the SoC. Again, a plan, a process, and a tool are needed to support this. Let’s discuss some of the impacts of these challenges. Disorganization, because you need to manage content across projects or potentially across systems, there can be just a lot of lost time, a lot of lost hours in terms of re-documenting things, and just generally a lot of confusion.

There can be traceability risks, especially if the data that you’re managing does not have a unified data model, or that data is just not integrated across systems. How can you be sure there are no traceability gaps? Future projects just take longer to spin up, because there’s a lot of rework. Yes, you can save that content as and work from there, but syncing those changes across the different copies that you’re making at scale just really isn’t possible without a tool like Jama Connect.

Let’s talk about some of the goals that we hope to achieve by adopting some of the strategies that I’ll outline. We want to scale SoC management, and again, what I think this means is developing a plan, using a tool that can support these use cases, and implementing a controlled yet flexible process. Leveraging libraries and variants to compile your IPs for reuse. This will be one of the strategies that we’ll discuss later on.

Immediate version clarity, both for software licensing and defective change management, and applying those changes across different projects in a scalable way, which leads us to the outcomes. What we hope to achieve by adopting some of these strategies we’ll streamline SoC projects coming down the pike by using and leveraging existing IP in a controlled and organized method. This will give us high-quality source control, using a library approach in Jama Connect, so that defects and changes can be applied to working projects at scale and easily.

Maintaining licensing becomes clearer in this library-managed system, and the path to regulatory compliance can even be eased, as with all the processes we’ve adopted, traceability risks can be mitigated and reduced. A look into live traceability is possible, and we’ll unpack that a little bit later in the webinar today. You can increase time to value, manage change, and increase product confidence with all of these strategies.

WATCH THE ENTIRE WEBINAR HERE:
Managing System-on-Chip (SoC) Complexity: Strategies for Scalable Design