Tag Archive for: Requirements & Requirements Management

Tag Archive for: Requirements & Requirements Management

How to Master Traceability in Medical Device Development

How to Master Traceability in Medical Device Development

As an engineer in the medical device industry, you’re tasked with creating innovative products that are both safe and effective. However, this core mission is often overshadowed by the immense pressure of regulatory compliance and documentation. As technology advances and products get more complex, that task gets even more complicated. Managing traceability between thousands of requirements, risk items, and test activities can feel like a “paperwork” burden that pulls you away from what you’d rather be doing: designing and testing new products.

This article offers a practical guide to transform traceability from a time-consuming chore into a strategic advantage. We’ll explore how to build a robust traceability model that not only satisfies regulators but also helps you build better, safer products faster.

TL;DR: Stop treating traceability as an end-of-project scramble. By implementing a single source of truth with Live Traceability™, you can connect requirements, risks, and tests in real-time. A modern platform like Jama Connect® automates this process, helping you identify gaps early, reduce rework, and free up your team for more efficient product development.

The High Cost of Inefficient Traceability

When traceability is managed with disconnected documents and spreadsheets, it becomes a significant bottleneck. This manual approach is not just inefficient; it introduces substantial risks that can derail a project and kill the team’s morale. For complex medical devices, the consequences of poor traceability are severe:

  • Project Delays: Manually creating and updating traceability matrices consumes hundreds of hours, often at the end of a project that results in pushing back launch dates.
  • Compliance Risks: Incomplete or inaccurate traceability is a common reason for audit findings and can jeopardize FDA submissions and technical file reviews under the EU MDR.
  • Increased Rework: Without a clear line of sight between requirements and tests, design changes can have unforeseen impacts, leading to costly rework late in the development cycle.
  • Reduced Innovation: Engineers spend valuable time on administrative tasks instead of focusing on design, testing, and innovation.

The key takeaway: Treating traceability as a final-step documentation exercise is a high-risk strategy. The true cost isn’t just the time spent on paperwork, but the project delays, compliance failures, and missed opportunities that result from it. You can assess your own risk by taking a Requirements Traceability Diagnostic.

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

How-To: Best Practices for Ensuring Medical Device Traceability

To move from a reactive to a proactive approach, you need to integrate traceability into the fabric of your development process. Here are four actionable steps to make that happen.

Step 1: Establish a Single Source of Truth

The foundation of effective traceability is a centralized platform where all product development data resides. When requirements, risk analysis, and test cases live in a single system, you eliminate the confusion and errors caused by separate documents.

A single source of truth ensures that every team member—from systems engineering to quality assurance—is working with the most current and approved information.

  • Benefit: Creates consistency and provides a complete, auditable record of your design history.
  • Impact: Reduces miscommunication and errors, ensuring all teams are aligned.

Step 2: Implement Live Traceability™

A static, manually created traceability matrix is outdated the moment it’s finished. Live Traceability, in contrast, creates a dynamic, real-time map connecting every requirement to its corresponding risks and test cases.

With Live Traceability, you gain instant visibility into the health of your project. If a requirement changes, you can immediately perform an impact analysis to see which downstream requirements, risk mitigations, and test items are affected.

  • Benefit: Allows you to identify and address gaps in coverage early in the process.
  • Impact: Drastically reduces audit preparation time and minimizes the risk of missing critical connections.

Step 3: Integrate Risk Management into Your Workflow

For medical devices, traceability isn’t just about connecting requirements to tests; it’s about proving that every potential hazard has been identified, analyzed, and mitigated. This is a core expectation of standards like ISO 14971.

By managing risk within the same platform as your requirements, you can directly link risk control measures to the design requirements that implement them. This creates a closed-loop process that demonstrates comprehensive risk management.

  • Benefit: Ensures product safety is a continuous focus that woven into all project milestones, not a separate, check-box activity.
  • Impact: Builds a safer, more reliable product and provides clear evidence of compliance for regulators.

Step 4: Streamline Collaborative Reviews and Approvals

Formal design reviews are a critical part of the development process, but they can be slowed down by manual feedback cycles via email or comments in disjointed documents. A modern platform streamlines this with a dedicated review center.

This allows stakeholders to comment, vote, and approve items in a structured, collaborative environment. All feedback is captured in one place, creating a clear and permanent audit trail of every decision.

  • Benefit: Accelerates feedback loops and decision-making.
  • Impact: Ensures that all approvals are documented and traceable, strengthening your Design and Development File.

From Burden to Benefit with Jama Connect

Implementing these best practices is far simpler with a purpose-built tool. Jama Connect is designed to help medical device teams master traceability and accelerate efficient product development.

By providing a single platform with Live Traceability, integrated risk management, and collaborative review workflows, Jama Connect helps you build your traceability matrix as you work. This transforms it from a document you create at the end of a project into a powerful, real-time tool you use throughout the project.

Customer success stories highlight the impact. For example, Dexcom achieved a 60% improvement in systems engineering efficiency by using Jama Connect to manage its complex requirements. Similarly, Vave Health significantly reduced the time spent on traceability matrices, accelerating its development and path to FDA clearance.

The most important benefit: Jama Connect empowers engineers to focus on what they do best—designing and building life-changing medical devices—by turning the “paperwork” of traceability into an automated, value-adding process.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

FAQs: Medical Device Traceability

Q: What is a traceability matrix in medical device development?
A: A traceability matrix is a document or table that demonstrates the relationships between user needs, design inputs (requirements), design outputs (specifications), risk control measures, and verification and validation activities (tests). While traditionally created in spreadsheets, modern solutions like Jama Connect provide Live Traceability, which is a dynamic, real-time view of these connections, making it far more accurate and less time-consuming to manage.

Q: How does traceability help with FDA and EUMDR compliance?
A: Regulatory bodies like the FDA (under the new QMSR) and the EU (under MDR) require manufacturers to prove that their device is safe and meets all specified requirements. A complete traceability record is the primary evidence used to demonstrate this. It shows auditors that every requirement has been tested, every risk has been mitigated, and the entire development process was conducted under a state of control.

Q: Can we integrate Jama Connect with our existing engineering tools?
A: Yes. Jama Connect is designed to serve as the central hub for requirements and risk management while integrating with other best-of-breed tools in your ecosystem, such as Jira, Azure DevOps, and various testing suites. This creates a connected toolchain that provides end-to-end traceability without forcing your teams to abandon the specialized tools they rely on.

Take Control of Your Traceability Process

Stop letting manual traceability processes create bottlenecks and introduce risk. By adopting an integrated approach, you can pass audits with confidence, accelerate your time-to-market, and empower your engineers to focus on innovation.

Ready to see how you can transform your product development process? Schedule a personalized demo to learn more about Jama Connect for Medical Device Development.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish.

Jama Connect® Features in Five: Co-Development with Partners

Discover how Jama Connect empowers seamless co-development with your partners! In this Features in Five session, Mario Maldari, Director of Product and Solution Marketing at Jama Software, demonstrates how Jama Connect’s Review Center enables secure collaboration, granular access control, and iterative feedback cycles. Learn how to streamline cross-company collaboration, maintain a single source of truth, and accelerate your time to market!

VIDEO TRANSCRIPT

Mario Maldari: Hello. My name is Mario Maldari, and I’m the Director of Product and Solution Marketing at Jama Software. Today, we’ll be discussing how Jama Connect allows for co-development with partners while maintaining full control over access.

In a co-development scenario, you can share a Jama Connect project with your partner and utilize our granular permission to control access and information. You can also utilize our comprehensive Review Center and invite partners and stakeholders to participate in requirement reviews. Jama Connect is number one in enabling partner codevelopment. Thousands of engineers are already collaborating across companies today.

Some of the unique Jama Connect features that enable this collaboration are multi-tenant SaaS, no IT involvement required, centralized control of user administration and access rights, a comprehensive and collaborative reuse center, cross-company collaboration, including at mentions, subscribing, and chat streams. The Jama Connect Review Center is number one in partner codevelopment reviews.

RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution

Maldari: Some unique Jama Connect features of our Review Center are iterative review cycles with a dedicated work stream for early-stage peer reviews and final approval reviews, reviewer and approval role control, approval role delegation, related items included in reviews for context and completeness, a reviewer role at no added cost. This includes external partners, stakeholders, allowing for co-development and collaboration. In this video, we will explore how Jama Connect’s Review Center enables co-development with partners.

Arms-length relationships are moving to co-development to speed time to market. Only Jama Connect enables you to include partners in your development process and control their access. Let’s explore how this is achieved in Jama Connect today.

Any artifact or set of artifacts in Jama Connect can be sent to the Review Center. Let’s select a set of stakeholder requirements and create a new review. There are a number of options and configurations that can be selected according to your review process. Internal reviewers can be added as approvers or reviewers. External partners and stakeholders can also be invited to the review simply by adding their email address. They are provided a free license that allows them to participate in the review as codevelopers or partners.

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

Maldari: This allows for all review comments and sign-off from internal and partner teams to be kept in Jama Connect as a single source of truth. In this case, Jim, the project manager, will add Mario as an external stakeholder to participate in the review. Mario will receive an email with instructions and a link inviting him to participate in the review. He can simply click on the link and is able to see all of the requirements that are part of the review and comment, approve, or reject as appropriate. Here is the email that Mario has received from Jim Arlo inviting him to participate in the review. You can click on the link, open the review, and Jama Connect’s simple UI provides an easy way to go through each requirement and collaborate with the internal team. Requirements can be approved or rejected, and new versions of the review created based on updates and subsequent revisions. This can be an iterative and collaborative process between internal teams and external stakeholders.

The end result is quality requirements that are agreed to by both teams. Jama Connect’s Review Center was designed for ease of use and for collaboration with both internal and external teams, allowing for Jama Connect to be the single source of truth for co-development teams. Thank you for watching this Features in Five video on how to use Jama Connect to co-develop with your partners and suppliers. For more information, please reach out to your customer success manager or go to our website at jamasoftware.com

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

Enhancing Collaboration for Distributed Teams
Enhancing Collaboration for Distributed Teams

Delivering high-quality, compliant, and complex products on schedule and on budget is never easy. Whether your hardware and software development teams are distributed globally or nationally, achieving the necessary alignment and coordination of work activities becomes a significant challenge. Engaging your supply chain presents even higher hurdles. This article provides practical insights into fostering effective team collaboration for distributed teams to ensure that your development projects remain on track and your corporate goals are met.

Unlocking Project Success with Structured Collaboration

Why is effective collaboration critical for distributed teams?

When teams operate in silos, the risk of miscommunication, delays, and budget overruns increases exponentially. Navigating different time zones, cultural nuances, and disparate toolsets can lead to information gaps and a lack of a unified project vision. Without a structured approach to collaboration for all internal and external teams, companies struggle to maintain the alignment and coordination necessary to meet aggressive deadlines and deliver products that satisfy customer and industry requirements. This challenge directly impacts your ability to innovate and compete effectively in the market.

How does ineffective collaboration jeopardize project success and regulatory compliance?

When teams aren’t communicating and coordinating, they often miss new or changed requirements or tests. This can lead to expensive rework to address quality or safety issues or project defects during development or product recalls or customer complaints after development. For companies in regulated industries such as medical devices, automotive, or aerospace & defense, these gaps can have severe consequences including failed audits and compliance that can prevent or delay delivery to customers. A lack of a centralized, auditable trail of decisions and reviews involving all necessary stakeholders makes it nearly impossible to prove due diligence which can put the entire development process at risk. Ensuring your teams are on the same page in adhering to standards and best practices is essential for navigating complex regulatory landscapes.

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

What tools centralize communication and streamline critical review cycles?

To overcome these hurdles faced by distributed teams, leading organizations adopt a centralized platform for requirements, risk, and test management that facilitates structured collaboration. Individual productivity tools such as email, documents, and spreadsheets are inadequate for managing the complexity of modern product development by distributed teams because they often result in conversation fragments and version control nightmares. A dedicated platform provides a single source of truth, ensuring every stakeholder contributing to the development process is working from the most current information. This centralization is the first step toward breaking down silos and fostering genuine team collaboration among distributed teams.

How does a platform like Jama Connect® foster seamless cross-function team collaboration?

Jama Connect is designed specifically to address the challenges faced by distributed teams by combining a single source of truth with a structured environment for communication and decision-making. Its intuitive, easy-to-use Review Center functionality allows internal and external stakeholders to provide critical input and feedback directly on requirements and test cases in a clear, contextual, and traceable manner. This eliminates the ambiguity of offline comments and ensures all feedback is captured and addressed systematically. This intuitive process keeps everyone aligned, regardless of their location or time zone.

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

What are the tangible benefits of Jama Connect’s structured collaboration?

By implementing Jama Connect, you have the solution for completing development on time and on budget. The platform enhances team and work alignment, which reduces costly rework and accelerates development cycles. In addition, you gain greater control and visibility into the development process, allowing you to address issues that the platform automatically identifies for you and ensure compliance with all applicable safety, quality, and other regulations. This leads to faster delivery of high-quality products or systems that meet customer requirements and strengthen your company’s market position.

Take the Next Step

Ready to transform how your distributed teams collaborate and innovate? See how Jama Connect provides a centralized platform that enables your teams to work together to gather input, streamline reviews, ensure compliance, and deliver innovative products on schedule.

Schedule a Jama Connect Demo Today

To learn more, watch a short video about Jama Connect’s powerful collaboration features:

Getting Started with Jama Connect: Collaboration

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mark Levitt and Mario Maldari.

Engineering Governance: The Engine Behind Automotive Excellence

In this blog, we recap “Engineering Governance:
The Engine Behind Automotive Excellence” – Click HERE to read the entire Whitepaper.

Engineering Governance: The Engine Behind Automotive Excellence

The automotive industry is a world of constant change. Engineering governance is the invisible engine that keeps everything humming smoothly.

Innovation to support AI-powered software-defined vehicles, electric and hybrid drivetrains, and sustainability initiatives are navigating where the automotive sector is going. But while technology makes headlines, what happens behind the scenes to manage the complexity of automotive development to stay on the right course is just as critical.

What Is Engineering Governance?

Engineering governance is a system of policies, processes, and standards that guides everything from vehicle design to production. It serves as the GPS for automotive engineering teams to ensure that they are building the right vehicles in the right way, so that every decision aligns with regulatory, safety, and quality standards and the broader goals of the company.  It helps with the unification of the hardware and software siloes to not only avoid defects resulting in costly recalls and accelerate product development, but also provide an holistic operational overview of the complete engineering organization reducing risks and driving efficiency.

When designing a new hybrid, for example, engineering governance ensures that the final product adheres to emissions laws, passes stringent safety tests, and meets customer expectations. It
touches every stage of a vehicle’s lifecycle — from initial design to when it rolls off the assembly line and beyond.

AI is accelerating development of systems to enhance safety, enable convenience, and make maintenance more effective. Engineering governance will ensure that concerns about cybersecurity risks and ethical decision-making are addressed. OEMs face the significant challenge of seamlessly integrating diverse software from hundreds of suppliers. Modern premium vehicles have more than 100 million lines of software code — far exceeding the 14 million lines of code in the Boeing 787 Dreamliner. Dealing with safe-critical, non-safe, secure, open-source, and proprietary software, each with its own requirements and standards, necessitates robust engineering governance, efficient collaboration, and cutting-edge tools to ensure that the systems coexist harmoniously.

RELATED: The Impact of ISO 26262 on Automotive Development

Why Engineering Governance Matters

For automotive companies, failure to follow strong engineering governance risks expensive recalls, lawsuits, and fines, as well as harm to customer health and property, leading to significant negative brand impact. Here’s why getting it right matters so much:

  1. Ensuring Compliance with Regulations: Automotive companies operate within a tightly regulated environment. Engineering governance provides a structured approach to ensure compliance with all relevant regulations across markets where vehicles are sold.
  2. Managing Risks Proactively: Helps identify and mitigate risks early before they escalate. Without comprehensive safety and quality testing, defects might surface after vehicles are delivered to customers, rather than during development when fixes are much less costly.
  3. Maintaining Quality Standards: A robust framework ensures that vehicles meet or exceed performance and reliability specifications without cutting corners during design, manufacturing, or testing.  It enables a comprehensive view of all aspects of vehicle safety by unifying hardware and software development siloes.
  4. Driving Innovation Responsibly: Innovation without governance can spiral into impractical or unsafe ideas. Engineering governance ensures innovation is balanced with feasibility, compliance, and cost control. Companies racing ahead with autonomous vehicle technology, for example, need engineering governance to ensure that these vehicles undergo rigorous safety tests, align with evolving regulations, and deliver innovations responsibly.
  5. Achieving Sustainability Goals: Sustainability has become a business imperative for automakers in response to demands from governments and consumers. Engineering governance helps automakers achieve sustainability goals by embedding eco-friendly practices into every stage of development and production.

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

Engineering Governance Scenarios

Here’s how engineering governance plays a role at every step in the development of any new vehicle or system:

  1. Design Phase: Ensures vehicles comply with emissions standards and fuel efficiency standards in the United States, the European Union, and other regions.
  2. Testing and Validation: Frameworks ensure rigorous testing of every component — from the engine to the suspension system and software. Engineers follow defined processes to simulate driving conditions to ensure safety and durability.
  3. Supply Chain Oversight: Identifies system or parts suppliers whose products and processes meet quality and sustainability standards.
  4. Post-Market Monitoring: Even after vehicles are sold, engineering governance mechanisms monitor performance through data collection to identify recurring issues and develop structured response plans to ensure quick fixes that reduce customer dissatisfaction.

For automotive executives, engineering governance is more than a technical concern; it’s a business strategy driving competitive advantage by ensuring that reliable, innovative, and compliant vehicles hit the market faster than the competition. It builds customer trust, bolsters investor confidence, and helps companies stay ahead of the constant changes in regulations.

How Jama Software Helps

Jama Software empowers automotive companies to excel in their engineering governance initiatives by providing a centralized platform called Jama Connect® that ensures traceability, compliance, and collaboration across complex development projects. By facilitating real-time alignment between teams and maintaining a clear connection between regulatory requirements, development processes, and business goals, Jama Connect helps streamline decision-making and reduce risk. This enables organizations to confidently manage innovation, comply with regulatory standards, and accelerate time to market — all while maintaining high levels of quality and accountability.

To learn more about Jama Connect for Automotive, visit jamasoftware.com/solutions/automotive/

TO DOWNLOAD THE ENTIRE WHITEPAPER, VISIT:
Engineering Governance: The Engine Behind Automotive Excellence

Onera Health Chooses Jama Connect® to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story

In this blog, we preview a section of our recent customer story. To download the entire story, visit “Onera Health Chooses Jama Connect® to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story”

Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story

About Onera

Onera Health develops clinical-grade remote diagnostics and monitoring solutions, making home polysomnography broadly accessible and user-friendly for anyone who needs it, wherever they are.

Customer Story Overview

Onera Health has developed a sleep diagnostic system utilizing four patch-based sensors that patients could apply at home. Initially, the Onera STS 1 product development team conducted pilot studies and relied on Microsoft Excel and Word to manage requirements and create the necessary documentation for successful Medical Device Directive (MDD) and Food and Drug Administration (FDA) submissions.

With the development of the company’s second-generation commercial product, the Onera STS 2, and its integration into Onera’s enhanced end-to-end solution, Onera Health took an active approach in recognizing and acknowledging the increased complexity of its second product. The company began seeking a more structured procedure for managing requirements, tests, and risks.

The new solution needed to provide better access, efficiency, and collaboration for teams working in different disciplines so they could accelerate development with confidence. Onera Health chose Jama Connect because it enabled faster iterations, greater consistency of requirements after changes are made, and visibility into risks and related mitigations.

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

With Jama Connect, Users Experience:

  • Faster iterations on requirements due to less time spent in alignment, review, and audit meetings
  • Consistency of requirements, terminology, configurations, and documents for all teams affected by design changes
  • Visibility into risk identifications and mitigations for internal and regulators’ teams

“We needed a more structured approach due to the complexity involved in maintaining consistency across our entire documentation set. With our first generation, tracking the impact of a design change or updates impacting multiple disciplines was time-consuming and came with its own challenges.” – PIETER ERMERS, FOUNDER AND VP QUALITY & REGULATORY, ONERA HEALTH

Challenges

Complexity of product design, regulations, and document strategy lacking efficiency, scalability, consistency, and accessibility.

Managing requirements and tests, while maintaining document consistency, was generally challenging due to product and regulatory complexity, as well as the limitations of an on-premises document database. Additionally, accessing the database required a VPN which can slow work or interrupt progress when the connection was down.

“We chose Jama Connect because of its intuitive user experience, cloud-based availability, and flexible output that our global team needed. Jama Software Consultants were very supportive in helping us understand how to set up Jama Connect to achieve our goals.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Evaluation

One cloud-based system, accessible and user-friendly, with integrated collaboration and reviews, automated test input, and flexible reporting.

The evaluation demonstrated that Jama Connect could easily be accessed and used to manage requirements, tests, and risk based on its intuitive user interface, authoring, collaboration, reviews, and verification. Automated input of test results and flexible output in generating reports provide a tailor-fit to the company’s needs.

“When making changes in a requirement used in multiple sensors, we must maintain consistency of requirements, tests, and documents across teams and disciplines. Jama Connect’s structured approach for automatically checking that everything is covered is very beneficial for us.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH

Outcomes

With Jama Connect, the Onera team has experienced the following benefits:

  • Faster iteration on requirements due to less time spent in alignment, review, and audit meetings
  • Consistency of requirements, terminology, configurations, and documents for all teams affected by design changes
  • Visibility into risk identifications and mitigations for internal and regulators’ teams

Learn how Jama Connect helps medical device companies succeed with higher quality and faster time to market.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development

Two photos of the speakers for this event on the topic of ASQMS and Automotive Compliance.

In this blog, we recap a preview of our recent webinar. Click HERE to watch it in its entirety.

Making Sense of ASQMS: A New Standard for Automotive Software Quality

The Next Automotive Software Standard Is Here. Are You Ready for ASQMS?

The shift toward software-defined, new energy, and intelligent vehicles is transforming the automotive industry. As vehicles become more reliant on complex software to power advanced features, autonomy, and connectivity, the need for robust quality management has never been greater. To meet this challenge, China’s CACPQSP introduced the Automotive Software Quality Management System (ASQMS).

In this blog, we recap a preview of our recent webinar in which hosts Sathihya Ramamoorthy (Jama Software) and Ronald Melster (Melster Consulting GmbH) discuss how ASQMS fits into the standards landscape and why it matters for your teams.

What You’ll Learn:

  • An overview of ASQMS, who published it, and why it matters
  • Key differences between ASQMS, ASPICE, and IATF, including new lifecycle requirements
  • Why ASQMS complements, rather than replaces, ASPICE
  • Practical tips for risk-based software classification and lifecycle coverage
  • Actionable next steps to strengthen software quality and efficiency

The Above Video Is A Preview – Click HERE To Watch The Entire Webinar

VIDEO TRANSCRIPT PREVIEW

Ronald Melster: Thank you very much for the warm introduction and thank you very much also for inviting me to today’s webinar. I am excited to be here with all of you and to share with you the information about this new standard ASQMS. So let’s get started and explore what the standard means for the automotive world and how we can best adapt to it. For those of you who don’t know me yet, my name is Ronald Melster. In the automotive world, I’m simply known as Ron. As one of Europe’s most experienced Automotive SPICE principal assessors, I have spent nearly three decades helping organizations transform their development processes. Since 2005, I’ve been guiding teams not just to achieve higher capability levels, but to truly understand the why behind effective processes. My journey began in the 1990s when I studied computer science in Berlin and Edinburgh, but I quickly discovered my passion for software engineering and processes. What started as a love for coding evolved into a mission to help teams balance structure with pragmatism.

Over the years, I have had the privilege of working with industry leaders like Bosch, Audi, Porsche, and Here Technologies. One of my biggest achievements was leading a Bosch development division with 7,000 engineers worldwide to capability level 3, proving that even larger teams can embrace systematic improvements. But here’s what I’ve learned. Assessments are not just about ratings. They’re about empowering people, building confidence, and creating sustainable change. Whether it’s functional safety according to ISO 26262, cybersecurity, or process improvement initiatives, I’m here as your mentor, coach, and sparring partner. Maybe you have heard the rumors about this new China standard and you want to learn more about it. You have come to the right place. Let’s start with the name of ASQMS, Automotive Software Quality Management System. That’s the full name of the standard, and yes, it’s a Chinese standard.

We will take that apart piece by piece in this webinar. So the first question is which body exactly published this ASQMS standard? And the answer is the Chinese Association of Consumer Products Quality and Safety Promotion, short CACPQSP. Say this three times. This body is dedicated to consumer rights and their safety and regulates consumer products, including cars. To promote this, they created the ASQMS standard and demand that each OEM selling cars in China needs to be certified according to the standard. So naturally, it applies to Chinese OEMs selling in China, and it also applies to European OEMs wanting to sell cars in China as well. And there’s more. The OEMs are required to request the certificate from their suppliers as well, so it also applies to any supplier tier two or tier one if they want to be part of the supply chain for cars sold in China.

Let’s have a look at why they created the standard and why we need another standard if we have Automotive SPICE or ASPICE. The reason for that is the dependency on software in the car. The complexity is growing rapidly. The number of technical and organizational interfaces gets bigger every day, and the cars increasingly rely on data coming from the outside. Let me share an observation with companies trying to reach capability level 2, according to Automotive SPICE. At the beginning of the project, the capability level is at a stable level 0. Then it takes one, or two, or even three years to get to level 1 and then to level 2. Then the project delivers the result and is finished. And the next project start again at level 0. I call this cycle the chainsaw or zigzag, up and down and up and down. It’s a huge waste of time and effort, and might have led to the ASPICE frustration, which we observed in networks like LinkedIn.

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

Melster: Why is that? Because the knowledge is not captured after the project in the company, nor is it standardized or rolled out. Only few companies have managed to establish a stable level 3 with a standard process according to ASPICE. Why can a project not start in a systematic way, aka level 2 or level 3, from the start of the project? This will also reduce the technical debt, which is built up every time a project starts from level 0. There are some of the reasons why this new standard was developed. We need a strong focus on software development. We need to include the software outside the vehicle, and we need to focus on the organization to provide standard process which is applied in each and every project in a similar way. And I might add that we need to take care of the software long after the initial development phase. In a world with rising cybersecurity issues, the software must be maintained and updated if new threats become known. Therefore, ASQMS includes the entire life cycle, including the termination of the software with a systematic deletion of all personal data.

Let’s talk about what’s inside the standard ASQMS and how it’s structured. The standard contains three kinds of requirements, which must be implemented by a company which wants to be certified according to ASQMS. The first one are basic practices, not base practices, but basic practices. They’re mandatory for all automotive development. The second kind of practices are advanced practices. They must be implemented by products which are safety or cybersecurity relevant. And the third type of requirements are recommended practices. They should be implemented by all software projects. The ASQMS standard follows a risk-based approach, which means that not all requirements, which are defined by the standard need to be implemented in each development program. For that, a classification is introduced, the two classes or types of software.

Type II is a software that carries a risk related to safety or cybersecurity, and type I is the rest of the software, which is not related to safety or cybersecurity. For type II software, the cybersecurity or safety-related, the basic practices are mandatory, and the advanced practices are mandatory. The recommended practices are recommended. For type I software, which are not as critical, only the basic practices are mandatory, and advanced and recommended practices are optional. ASQMS clusters the processes into three groups: operational processes, supporting processes, and system management processes. The operational processes include project management and the entire V-model with requirements engineering, architectural design, detailed design and implementation, unit verification, integration, and verification testing.

Apart from these well-known engineering processes, the following processes are defined as part of the operational processes: supplier management, software release, software deployment, software maintenance, user information management, and software termination. So there’s some overlap and some new processes. The supporting processes include some which we already know from Automotive SPICE like configuration management, problem resolution management, change request management, and of course, quality assurance. They even have the same process names. The basic practices may differ in some aspects. And some new supporting processes are introduced like documentation management, equipment and facilities, knowledge management, revenue management, and externally supplied products and services, which includes the management of free and open-source software.

RELATED: Jama Connect® for Automotive

Melster: With the system management processes, something completely new is introduced. They’re not to be confused with the system development processes, which we know from ASPICE. System here refers to the quality management system in the name of ASQMS. So it’s similar to ISO 9001, or ITF 16949, or an information security management system, which gets certified by TSACS. These processes include the scope and the context of the organization, the quality management system fundamentals like quality policies and roles, personnel management, performance evaluation, and the continuous improvement process. In this next section, I will highlight some of the key changes when we compare Automotive SPICE with ASQMS. The first one is the software, which is in the scope of the standard ASQMS. The requirements are not only mandatory for in-vehicle software, which many of us have known for a long time, but also for software outside the vehicle is in scope.

This includes any software in the cloud providing data to the vehicle or to an entire fleet. It furthermore includes any system along the roads, so-called roadside systems. Again, exchanging information with the car or even controlling the behavior of the vehicle. And it applies to the software tool chains which are used for software development and maintenance. The next important change is the lifecycle. Automotive SPICE development projects typically stop with the release of the finished software, whatever this means. The maintenance phase is usually left out or ignored, and really no one thinks about the termination of the software in an ASPICE project. This will change with ASQMS. The entire lifecycle of the software must be covered. This only starts with the initial development phase and must be continued with the ongoing maintenance of the software until the termination of the software. You might want to know, what is the termination more than switching off the software? Well, many software instances store data, oftentimes personal data, and this information must be securely deleted as part of the termination.

Many companies claim that they are ASPICE level 2 certified. However, this is not true. There is no such certification. What they have reached in most cases is a level 2 in one project at a certain time. So this does not apply to any other project in the same company without performing additional assessments, nor is the claim true in the future or after the assessment for the same project. So here’s the last key change I will talk about. ASPICE assessments are statements about projects at a certain point in time. This statement cannot be carried over to any other project in the company, nor is it valid in the future. ASQMS, on the other hand, focuses on the organization. This means that the organization must establish processes to fulfill the requirements and maintain them in each and every development project. This also includes internal auditing activities to make sure that all projects follow the defined rules and methods. And as I’ve mentioned earlier, it also includes processes to provide competence staff to the project. Only then will the company get the ASQMS certificate, which is published by an external auditor.

So what have we learned today about how ASPICE and ASQMS can work together? First, ASPICE integration. ASQMS will not replace Automotive SPICE. Instead, ASPICE can be used to show the conformance with the overall standard processes. And if you are already using ASPICE at the project level, these methods can be scaled to the entire organization using the approach of ASQMS. Second, both standards have shared goals. They’re built on the same fundamental principles, traceability, clear structure, and well-defined roles. Whether you’re working on a senior development project or managing quality across multiple teams, these core elements remain the same. And finally, ASQMS is extending the scope. Here’s where ASQMS goes beyond traditional ASPICE scopes. It adds organizational elements like leadership development, culture building, and personnel focus. The reality, ASPICE and ASQMS work as a partner, not competitors. Automotive SPICE gives you project-level excellence while ASQMS builds the organizational capability to sustain that excellence across all your software activities. Together, they create a comprehensive quality approach that works at every level.

This Has Been A Preview of Our Webinar, To Watch the Full Webinar, Visit:
Making Sense of ASQMS: A New Standard for Automotive Software Quality

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

Designing and constructing nuclear systems and facilities, with instrumentation and control systems, is one of the most intricate and regulated endeavors any organization can undertake. The process of managing, defining, and tracing functional, safety, security, design, performance, independence, reliability, and special treatment requirements for complex nuclear reactors, along with their facilities, systems, subsystems, structures, and components, is compounded by strict, country-specific regulatory guidance and standards.

The design process is iterative and driven by continuous risk, safety, hazard, accident, and security analysis and mitigations. Revisions during and post-design and construction, based on safety/risk assessments and regulatory feedback lead to rework and reengineering, increasing costs and elongating timelines.

Effective requirements management, end-to-end traceability across the entire systems engineering process, continuous risk analysis and mitigations across the entire design cycle, and a single source of truth for systems engineering data aggregated across the digital thread are critical for project success. Failure to accurately categorize safety and security functions, classify structures, systems and components (SSCs), and assess the criticality of initiating events and hazards in compliance with the applicable regulations (IEAE, ONR, etc.) can delay certifications and project completion, dramatically increase costs, and jeopardize the safe state of the nuclear plant.

KEY BENEFITS

  • Streamline safety design assessments: Jama Connect offers a single source of truth for the digital safety assessment of a nuclear system, including qualitative hazard evaluations, probabilistic safety assessments, design failure, accident, and dose consequence analysis, FHA, security analysis, and combined risks mitigations.
  • Enhance collaboration across development teams and supply chain: Jama Connect natively enables co-development within the supply chain and external subcontractors, and improved communication and alignment between cross-functional teams and with external safety assessors.
  • Achieve end-to-end traceability across your development toolchain: Jama Connect’s Traceability Information Model™ outlines an end-to-end process for the requirements and design definition and decomposition, V&V, risk/safety/security analysis, and system implementation. With Live Traceability™, exchange system implementation specific data like models, architectures, parts/assemblies, tasks continuously with MBSE, PLM, work management, and P&ID tools.
  • Automate risk categorization and classification: Replace manual, error-prone categorization of risks and classes by letting Jama Connect automatically assess and calculate the criticality, categorization and classification of events, functions, and SSCs.

Jama Connect for Nuclear Reactor Design and I&C Development is purpose-built to guide engineers through the systems development and digital safety assessment of a nuclear system, automatically measure the completeness and quality of traceability across the entire digital thread, and enable the automated creation of digital safety reports.

Jama Software’s nuclear framework is oriented towards and based on the guidance of the NRIC for the usage of digital engineering tools for nuclear DSAs (digital safety assessments), the guidance of IAEA and ONR for the Categorization and Classification of Functions and SSCs, and IEC 61513, and IEC 61508 for the development of I&C systems.

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

Here’s how Jama Connect can help your team streamline processes, improve safety outcomes, and meet regulatory requirements:

End-to-End Traceability Across All Levels

With Jama Connect, you can ensure complete traceability across the design and engineering process – from product definition and design to V&V, safety and security classifications, categorizations and analysis, and product implementation. Our platform connects every design element — from mission-level objectives down to individual components, assemblies, and parts. Live Traceability not only satisfies regulatory demands but also provides critical insights into how changes at any level and any stage impact the entire system.

  • Traceability at every level: From mission needs and platform designs, to systems, subsystems to individual components, Jama Connect traces risks, requirements, V&V, and implementation elements are connected in an iterative, risk-driven process.
  • Event-function-SSC traceability: Map initiating events, safety, and security functions, and SSCs seamlessly, helping ensure safety-critical events are covered at every level.
  • Dynamic risk-response integration: Feed critical information like initiating events, identified hazards, safety, security and reliability requirements, and special treatments directly into the design, ensuring risks are evaluated and mitigated throughout the lifecycle.

Streamlined Safety Design Assessments

Regulatory requirements for nuclear reactor certification differ from country to country, but the principles of risk/safety/security analysis, safety and security classification, and categorization remain universal. Jama Connect simplifies this process by guiding teams through compliance-specific workflows.

  • Safety and security classification and categorization: Automate initial and final classification of safety/security functions, SSCs, and events. Automatically assign safety categories using calculated fields and lookup metrics based on global or country-specific nuclear standards.
  • Iterative compliance support: Conduct preliminary safety assessments early and refine security functions as the design evolves. Ensure that every regulatory stage is met with precision, from early safety categorizations to final licensing approvals.
  • Digital export for documentation: Generate detailed certification-ready documentation of classification assignments, risk analyses, and hazard outcomes for key documentation items like safety and security cases or preliminary and final design safety reports.

Seamless Integration Across Digital Engineering Tools

To ensure every aspect of the development process stays connected and enable the DSA (Digital Safety Assessment), Jama Connect integrates with industry-standard tools used for model-based systems engineering (MBSE), product lifecycle management (PLM), and after simulation:

    • MBSE: Collaborate effectively by connecting Jama Connect with tools like Cameo Systems Modeler (aka CATIA Magic) or Enterprise Architect to exchange architecture, models, and design data.
    • PLM: Sync parts, assemblies, and change requests with PLM tools like PTC Windchill, Aras PLM, or Siemens Teamcenter to manage parts and mechanical implementations efficiently.
    • P&ID: Diagram synchronization (either direct or via PLM) with tools like PTC Creo or Siemens NX.
    • Software development and work management: Easily sync tasks, stories, and epics with tools like Jira or Azure DevOps to ensure software requirements are implemented.
    • Digital threads: Create and manage a fully integrated digital thread that ties all relevant data from requirements and designs, V&V, MBSE, PLM, simulation and visualization, safety assessment, and risk management, enabling end-to-end traceability, completion measurements, change impact analysis, and the automatic detection of gaps and risks.

Risk Analysis and Hazard Management

Risk analysis is the backbone of safety in nuclear reactor design. Jama Connect supports rigorous risk, safety, and security analysis throughout the iterative design lifecycle, from the initial qualitative hazard evaluation to the analysis of initiative events, classification and categorization of functions and SSC, DID analysis to the probabilistic safety assessments, SSA, and DCA.

  • Initiating events from qualitative hazard evaluation: Identify events that could jeopardize the safe state of the nuclear power plant. operation, including those rooted in design, external hazards, or past regulatory findings.
  • Hazard analysis and mitigation – probabilistic safety assessment: Collect and analyze identified hazards, assess severity, and create safety requirements that feed directly into system updates. Out of the box HARA and HAZOP data models.
  • SAA, FHA, DQA, and combined risks: Conduct severe accident analysis, fire hazard analysis, dose consequence analysis, combine/enveloped risk assessments, and derive mitigations and special treatments as part of Jama Connect’s end-to-end traceability.

RELATED: Overcoming Top Challenges in the Energy Storage Industry with Jama Software

Enhanced Efficiency and Collaboration

By centralizing all information within a single source of truth, Jama Connect eliminates inefficiencies, reduces rework, and fosters alignment between teams.

  • Agile-compatible iterations: Adapt requirements and designs iteratively as new risks or design details emerge.
  • Collaborative team environment: Share updates and insights in real time, ensuring stakeholders, engineers, and regulators remain aligned at every stage. Easy to initiate and complete reviews and approvals.
  • Automated workflows: Save time by automating time-intensive, repetitive tasks like hazard categorization and safety classification.

AI-enabled Intelligent Engineering

AI analysis and automation with Jama Connect Advisor™ improves productivity and product development outcomes.

  • Requirements quality intelligence: Enhance the quality and clarity of requirement language to significantly reduce a major cause of defects.
  • Test case intelligence: Streamline verification by automatically generating test cases derived from requirements.

For additional AI initiatives under consideration, go to labs.jamasoftware.com

Organizations at the forefront of nuclear innovations — including those overseeing and developing small modular reactors (SMRs) — recognize Jama Connect as a transformative tool in navigating the unique challenges of the industry.

From guiding teams through compliance workflows to empowering iterative risk analysis, Jama Connect for Nuclear Reactor Design and I&C Development is reshaping how the nuclear industry approaches design and certification. Its ability to combine traditional systems engineering approaches with modern digital iterative processes and digital safety assessments are redefining what’s possible in a nuclear reactor development.

To learn more about managing your nuclear requirements, tests, and risks with Jama Connect, visit jamasoftware.com

TO DOWNLOAD THE FULL DATASHEET, VISIT: Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect for Nuclear Reactor Design & I&C Development

Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect®

In this blog, we recap our recent customer story, “Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect” – Click HERE to download it in its entirety!

Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect®

Centralized requirements, Live Traceability™, and enhanced collaboration power Dexcom’s development of life-changing CGM technology.

About Dexcom:

  • Develops, manufactures, produces, and distributes Continuous Glucose Monitoring (CGM) systems for diabetes management
  • Headquartered in San Diego, California, USA

Dexcom was founded in 1999 to make diabetes management better with the world’s first real-time, integrated CGM system, the Short-Term Sensor (STS). This, and subsequent generations of the device now named the G series, combines hardware, software, and firmware to deliver an optimal user experience for making decisions about insulin and food intake.

After most of its history as a single product company, Dexcom developed Stelo, a wearable glucose biosensor available over-the-counter for people with type 2 diabetes who don’t require insulin.

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

CHALLENGES

  • Siloed Tooling: A document-centric approach and legacy tools created barriers to adoption and collaboration across engineering disciplines.
  • Traceability Gaps: Lack of a unified view of traceability made change management complex and created confusion across teams.
  • Regulatory Overhead: Manual processes for generating regulatory document templates caused significant delays and administrative burden.
  • System Complexity: Managing a complex set of interconnected hardware, software, and embedded requirements lacked a single source of truth.
  • Disconnected Ecosystem: Poor connectivity between requirements management and other engineering tools hindered end-to-end visibility.

Dexcom’s products combine software, hardware, and firmware, each with their own requirements and tests that must be managed and traced for compliance. As the company scaled, the existing processes, which relied on a mix of legacy tools, spreadsheets, and documents created information silos. Teams were often uncertain if they were working with the latest requirements, leading to rework and inefficiencies.

Generating audit-ready documents for regulatory compliance was a time-consuming, manual effort. The engineering and quality organizations invested significant time in manual documentation to ensure their products were always safe, effective, and compliant.

“We have a lot of smart people who joined Dexcom with expectations about doing great things. Having them spend a significant amount of their time manually copying and pasting in spreadsheets and Word documents is not the best use of their talent and expertise,” says Sri Harsha Maramraju, Senior Manager, Systems Design Engineering at Dexcom

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

EVALUATION CRITERIA

  • A central repository to keep all stakeholders informed of requirements status and changes.
  • An intuitive user experience to encourage broad adoption and cross- functional collaboration.
  • Full end-to-end traceability of all requirements and tests to support design controls and compliance.

Dexcom identified the need for a modern, centralized platform to manage requirements, tests, reviews, and documentation. The goal was to find a system with an intuitive interface and clear traceability to improve efficiency, stakeholder engagement, and compliance readiness. After a thorough evaluation of several leading solutions, the stakeholders selected Jama Connect. The platform’s exceptional usability, robust traceability visualization, and deep-rooted acceptance in the medical device industry made it the clear choice.

Key evaluation areas where Jama Connect excelled were its ease of use and powerful document generation capabilities. Another critical factor was its ability to provide clear visibility into the end-to-end traceability of all hardware, software, and firmware requirements and tests.

“Other tools have traceability, but only Jama Connect has a visual, configurable model that shows exactly what traceability looks like and accommodates our product’s complex configuration.” Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

For regulatory compliance, Jama Connect stood out with its out-of-the-box framework for medical device development, which simplifies alignment with stringent quality and safety standards.

“The built-in support for standards like ISO 14971 and the validated package included with Jama Connect give us the confidence to demonstrate that we are following industry best practices,” says Maramraju.

RELATED: Jama Connect for Medical Device Development

OUTCOMES

  • Streamlined change management and reviews for monthly releases using Jama Connect’s Review Center.
  • Achieved a 60% productivity boost for the systems engineering team, enabling faster project completion.
  • Successfully migrated active projects to Jama Connect, ensuring a smooth transition to a modern platform.
  • Driving reuse of requirements and tests across projects to support product line engineering (PLE) goals.

“If you’re building a centralized ecosystem for product development and design controls for the long term, you can rely on Jama Connect. Its usability, traceability, and industry-wide acceptance make it a cornerstone of our engineering process.” – Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom

Dexcom now depends on Jama Connect to efficiently manage requirements, changes, and reviews for its aggressive release cadence. Having one centralized place for these activities has improved systems engineering efficiency by 60%. The intuitive collaboration and review functionality in Jama Connect has increased stakeholder engagement. Quality and Regulatory teams now actively participate in the process within the tool, appreciating the structure and auditability it provides. “The conversation has shifted. Instead of discussing tool limitations, our teams now have productive, data-driven discussions about the work itself within Jama Connect. When other departments see what we are doing, they ask how they can get their projects onto the platform too,” says Maramraju.

Jama Connect’s Live Traceability™ has enabled Dexcom to track requirements through all stages of development, with integrations that sync requirements data to development activities in other tools like Jira. Looking forward, Dexcom is leveraging Jama Connect to drive reuse and synchronization of requirements across different platforms, a key step toward their product line engineering goals.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect

AI in MedTech: Transforming Device Innovation and Quality

AI in MedTech: Transforming Device Innovation and Quality

No matter where you turn these days, it is nearly impossible to escape the influence of AI. The MedTech industry is no different and stands at the brink of an AI revolution. From smarter devices to streamlined quality systems and even regulatory reviews, AI is poised to become a powerful tool across the product lifecycle.

Despite the potential, MedTech companies are lagging a little behind other industries when it comes to the use of AI. Recent industry surveys reveal that while 51% of high-tech companies have successfully integrated AI into their operations, only 24% of medical device organizations have achieved similar adoption rates. This gap represents an unprecedented opportunity for forward-thinking MedTech companies to gain competitive advantage through responsible, intelligent use of AI.

The FDA’s recent appointment of Jeremy Walsh as Chief AI Officer signals a clear regulatory shift toward embracing AI technologies that can accelerate device development while maintaining rigorous safety standards. Organizations that strategically implement AI across their device development, quality management systems, and regulatory processes will be positioned to deliver safer products faster while reducing operational costs.

AI-Enabled Medical Devices: The Next Generation

AI is increasingly embedded directly into medical devices, enabling real-time diagnostics, predictive analytics, and enhanced imaging. In fact, the FDA authorized 235 AI-enabled devices in 2024 alone, the most in its history.

Despite the success of an increasing number of devices being launched, much still needs to be done to ensure the devices are safe and meet their intended purposes.

The Validation Imperative

Recent research published in JAMA Health Forum analyzed 950 AI-enabled medical devices and found a concerning trend; devices without proper clinical validation were significantly more likely to be recalled. The study revealed that 43% of all recalls occurred within one year of FDA authorization, with diagnostic errors and functionality delays being the most common causes.

This data highlights a critical responsibility for manufacturers; robust clinical validation must be built into your AI device development process from day one. Companies that prioritize validation studies demonstrate measurably better post-market performance and reduced recall risk.

Practical Implementation Strategies for AI-enabled Devices

  • Start with Data Quality: AI algorithms require clean, structured datasets to function effectively. Implement data governance protocols that ensure your training data meets the highest quality standards.
  • Design for Continuous Learning: Modern AI-enabled devices benefit from continuous monitoring and improvement. Build infrastructure that supports ongoing data collection and algorithm refinement while maintaining regulatory compliance.
  • Plan for Regulatory Pathways: The FDA’s 510(k) process for AI devices is evolving rapidly. Stay informed about emerging guidance documents and consider engaging with FDA early in your development process through pre-submission meetings.
  • Implement Robust Testing: Beyond clinical validation, establish comprehensive testing protocols that evaluate your AI systems under real-world conditions, including edge cases and unexpected inputs.

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

AI in Quality Management Systems: Efficiency Through Intelligence

AI is not just for use within a device; it can transform operations too. From document generation to requirements management to supplier evaluation, AI can dramatically reduce manual effort and improve accuracy. Yet, only 10% of Medtech companies report measurable value from AI so far, compared to 24% across other industries. Quality management represents one of the most promising applications for AI in MedTech, where document-intensive processes create natural opportunities for automation and optimization.

Document Intelligence and Process Automation

AI-powered quality management systems can transform time-consuming manual processes into streamlined, automated workflows. Leading organizations report 60-70% reductions in initial document drafting time and weeks of improvement in overall review cycles when implementing AI solutions for regulatory document generation.

The key to success lies in establishing proper document management infrastructure before deploying AI tools. When quality teams maintain organized, structured document systems, AI can effectively analyze historical deviation reports to identify emerging patterns, generate compliance documentation that aligns with current specifications, and automate routine quality review processes.

Strategic Implementation Approach

  • Assess Your Document Infrastructure: Evaluate whether your team can rapidly locate current versions of critical documents and whether workflows are standardized across departments. These capabilities directly determine AI implementation success.
  • Start with High-Volume, Low-Risk Processes: Begin AI implementation with routine documentation tasks like generating standard operating procedures or compiling reports. This approach allows teams to build confidence while minimizing regulatory risk.
  • Maintain Human Oversight: Position AI as a capability enhancement rather than human replacement. Quality professionals should conduct comprehensive reviews and maintain final approval authority for all AI-generated content.
  • Establish Clear Governance: Create company-wide guidelines that specify which quality processes can utilize AI assistance, and which require traditional human-driven approaches. This clarity ensures regulatory compliance while capturing efficiency gains.

Regulatory Bodies Embrace AI: The FDA’s Digital Transformation

The regulatory landscape is rapidly evolving to accommodate AI technologies. In a major shift, the FDA announced it will use AI to assist with scientific reviews across all centers by mid-2025. Following a successful pilot, the agency is deploying generative AI tools to reduce review times and eliminate repetitive tasks.

What This Means for MedTech Companies

The FDA’s AI implementation aims to reduce non-productive busywork and accelerate review times for new therapies and devices. This regulatory modernization creates opportunities for companies that align their submission strategies with the FDA’s digital capabilities.

  • Prepare for AI-Assisted Reviews: Structure your regulatory submissions to work effectively with AI-powered analysis tools. This includes using standardized formats, clear section headings, and consistent terminology throughout your documentation.
  • Leverage Data-Driven Insights: The FDA’s AI systems will likely identify patterns across submissions that can inform your development strategy. Companies that maintain robust data collection and analysis capabilities will be better positioned to benefit from these insights.
  • Stay Informed on Evolving Guidance: The FDA has indicated that more details on their AI initiative will continue to be released. Monitor these developments closely and consider how they might impact your regulatory strategy.

Building Regulatory-Ready AI Systems

When developing AI-enabled devices, design your systems to generate the comprehensive documentation that regulatory bodies require. This includes maintaining detailed training data records, algorithm performance metrics, and clinical validation evidence that demonstrates real-world effectiveness.

How Jama Connect® Can Accelerate Your AI Journey

Requirements management plays a critical role in successful AI implementation for MedTech companies. Jama Connect provides the structured foundation necessary for AI-enabled development processes.

Jama Connect Advisor™ leverages natural language processing to help teams author requirements quickly and accurately, ensuring that AI system specifications meet the highest quality standards from the outset. This AI-powered feature analyzes requirements against industry best practices such as INCOSE and EARS, providing immediate feedback that improves requirement quality and reduces development risks.

The platform’s comprehensive Live Traceability™ capabilities ensure that AI system requirements remain connected to design decisions, test results, and regulatory submissions throughout the development lifecycle. This end-to-end visibility is essential for demonstrating compliance and supporting regulatory submissions for AI-enabled devices.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Your Next Steps Forward

The intersection of AI and MedTech presents unprecedented opportunities for organizations willing to invest in the proper foundation and strategic approach. Companies that begin building their AI capabilities now will be positioned to lead the industry as regulatory frameworks mature and competitive pressures intensify.

The key to success lies not just in adopting AI technology, but in implementing it thoughtfully within robust quality management and regulatory compliance frameworks. Organizations that prioritize data quality, maintain human oversight, and align their AI strategies with evolving regulatory expectations will realize the greatest benefits from this transformational technology.

Ready to explore how AI can enhance your MedTech development processes? Book a demo with Jama Software to discover how our AI-powered requirements management solutions can help you build safer, more effective medical devices while streamlining your path to market.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish.

Jama Software Launches Jama Connect® Availability in AWS Marketplace

Jama Software, the industry-leading requirements management and traceability solution provider, announced today that Jama Connect, and its add-ons, Jama Connect Interchange™, and Jama Connect Advisor™ are now available in AWS Marketplace, a digital catalog with thousands of software listings from independent software vendors that make it easy to find, test, buy, and deploy software that runs on Amazon Web Services (AWS).

Jama Connect, designed for teams prioritizing precision and collaboration, streamlines requirements gathering, management, and validation with unmatched efficiency. Now available in AWS Marketplace, customers can easily access Jama Connect, along with Jama Connect Interchange and Jama Connect Advisor—simplifying purchase, management, and integration while enhancing traceability, reducing risks, and accelerating time to market.

“Jama Software’s partnership with AWS highlights our commitment to cloud native and scalable cloud technology. Our collaboration with AWS allows us to work hand in hand with their consultancy services to deliver best of breed cloud native and scalable cloud solutions to our clients. AWS is committed to providing leading edge AI technologies in a ubiquitous manner to their client base. Jama Software leverages this to deliver secure, ethical, and reliable AI technology at the speed of market. Our recent public listing on the AWS marketplace furthers our commitment to this partnership and the success of our clients.” – Jim Davidson, Chief Technology Officer at Jama Software

Jama Connect and its add-ons, Jama Connect Interchange and Jama Connect Advisor are now generally available in AWS Marketplace. For more information on Jama Software and its offerings, please visit https://www.jamasoftware.com/.

To read the complete press release, click here.

About Jama Software

Jama Software is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.

For more information about Jama Connect services, please visit jamasoftware.com