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 […]
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 […]
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 […]
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, […]
Preparing for the FDA’s QMSR: Your Guide to Compliance Success “The only constant in life is change.” Those words, often attributed to the Greek philosopher Heraclitus, seem especially true in the medical device industry. Industry veterans have experienced a constant evolution of the regulations over the past 10 years. There was the update to ISO […]
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, […]
Legacy Requirements Tools Present Modern Performance Challenges When evaluating requirements management platforms, response time emerges as a critical factor that influences user adoption, team efficiency, and project success. Today’s modern engineering projects demand more than legacy solutions can deliver. The speed at which teams can access, modify, and collaborate on requirements directly impacts project timelines, […]
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 […]
Navigating AI Safety with ISO 8800 in Road Vehicles Editor’s Note: This blog post is based off of content from our recent webinar, presented by Matt Mickle and Jody Nelson from SecuRESafe (SRES). To learn more about how SRES can help your team develop responsibly safe and secure products for the evolving automotive and industrial […]
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) […]
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