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 […]
Ensuring Quality and Reliability in Automotive Software Development: An Overview of ASPICE 4.0 ASPICE (Automotive SPICE) 4.0 is a process assessment model tailored specifically for the automotive industry to ensure the quality and reliability of software and system development processes. It is part of the larger ISO/IEC 330xx family of standards and is derived from […]
3 Lessons Learned From EU MDR Implementation To Ensure IVDR Adoption In the previous article, “How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint,” we discussed key factors for maintaining operational excellence to achieve cost reduction, enhanced compliance, and support global footprint. In this article, we shift our focus toward […]
Mastering ISO/IEC 27001: A Guide to Information Security Management Understanding Information Security Management Information security, often referred to as cybersecurity, is a critical aspect of modern technology and business operations. It encompasses the protection of sensitive data, systems, and networks from unauthorized access, disclosure, disruption, modification, or destruction. The evolution of information security practices has […]
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