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 […]
Achieving Success in Energy Storage Development: Tips & Best Practices Are you prioritizing the safety and success of your energy storage systems (ESS) development? Teams developing ESS must prioritize product safety and effectively navigate the certification process. By learning best practices and gaining insights into Underwriter Laboratories (UL) standards, they can enhance safety and ensure […]
How to Overcome Development Challenges: Proving Regulatory Compliance in Complex Product and Systems Development As we enter the second half of 2024, development of complex products and systems often encounters the intricate web of regulatory compliance. From medical devices and automotive components to aerospace systems and software applications, ensuring adherence to stringent regulations is critical […]
Simplify Audit Documentation by Leveraging the Power of an Itemized Database How to enhance efficiency, auditability, and stay ahead of the competition with Jama Connect® for Medical Device Development In the current landscape of medical device and life sciences development — in addition to facing relentless pressures to innovate, remain competitive, and release quality products […]
The Top Six Things You Should Know About In the quest for innovation, product testing, compliance, and safety certifications remain key to accessing markets and gaining customers. No one wants to buy a product, service, or process that hasn’t been thoroughly vetted by an independent body. In the context of global markets, few certifications carry […]
. Navigating the Shift: From Machinery Directive 2006/42/EC to Machinery Regulation EU 2023/1230 Change is inevitable, especially in regulatory frameworks governing industries. In Europe, the transition from the Machinery Directive 2006/42/EC to the new Machinery Regulation EU 2023/1230 marks a significant step forward in ensuring safety, innovation, and harmonization in the machinery sector. This transition […]
IVDR Common Errors: Navigating Notified Body Expectations Explore the notified body process and IVDR technical documentation with experts Margot Borgel, Director of IVD Global Regulatory Affairs at RQM+, and Vincent Balgos, Director of Medical Device Solutions at Jama Software®. You will gain a thorough understanding of these topics and more: The notified body’s approach to […]
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