9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond Global frameworks offer valuable insights for Europe as the region is currently working to refine its regulatory systems. While Europe is a significant player in the medical device market, the MDR transition has created challenges driven in part by higher […]
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated this recent press release from the U.S. Food & Drug Administration, titled “FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices” and originally published on January 6, 2025. FDA Issues Comprehensive Draft Guidance […]
Navigating the updates to ARP4754B can be challenging. Understanding new safety analysis methods, validation and verification flexibility, and strategies to mitigate unintended behaviors is crucial for advancing aerospace development and ensuring compliance. Join us as Cary Bryczek, Director of Aerospace and Defense Solutions at Jama Software, shares practical tips for engineers and quality teams to […]
Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges Jama Software made its debut appearance at 2024 MedTech Conference in Toronto, CAN recently, and it was an inspiring experience. In addition to meeting passionate medical technology developers, learning the latest innovation trends, and establishing networking connections, I had the […]
Integrate DoD MIL-STD-882E Risk Management with Systems Engineering Using Jama Connect® for Defense Systems Align hardware and software systems safety using Jama Connect as your single, secure platform for requirements engineering, risk analysis, and test management. Military departments and defense agencies must follow the MIL-STD-882E Standard Practice for System Safety to ensure safety throughout the […]
Strategies for Mitigating Software Defined Vehicle (SDV) Development Risks and Reducing Costly Recalls Reduce the risks of product rework and recalls by using tools that enhance the efficiency and accuracy of requirements management and aid in compliance with UL 4600, the Standard for Safety for the Evaluation of Autonomous Products. The shift to software defined […]
Achieving ASPICE 4.0: Overcoming Key Challenges The path to ASPICE 4.0 compliance can be complex. Gaining a deeper understanding of traceability requirements, process consistency, verification criteria, and special characteristics is essential to improving your development processes and achieving compliance. Join us as Sathiya Ramamoorthy – Senior Solutions Consultant, Jama Software, and Ronald Melster – Managing […]
Understanding UL 4600: Ensuring Safety for Autonomous Products The rapid development of autonomous technology has ushered in a new era of innovation, promising to transform industries ranging from transportation to manufacturing. However, with great innovation comes the paramount responsibility of ensuring the safety and reliability of these autonomous systems. Enter UL 4600, a comprehensive standard […]
Understanding ALKS 157: Ensuring Safety and Compliance with Automatic Lane-Keeping Systems As the automotive industry shifts toward increased automation, technologies like Automatic Lane Keeping Systems (ALKS) are playing a crucial role in improving both safety and convenience. ALKS, regulated by the ALKS 157 standard, is a key technology driving the advancement of advanced driver-assistance systems […]
Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions Update: August 7, 2024 The revised part 820 is now titled the Quality Management System Regulation (QMSR). When referring to the rule that is currently effective, the FDA uses the term “Quality System (QS) Regulation” or “QS regulation.” Because both […]
CONNECT WITH US
USA
135 SW Taylor Suite 200
Portland, Oregon, 97204
EUROPE
Amsterdam Queens Tower
Delflandlaan 1, 1062EA Amsterdam
The Netherlands
© 2025 Jama Software