Medical device risk management is the systematic application of management policies, procedures, and practices to identify, evaluate, control, and monitor risks throughout the device lifecycle. Under the QMSR and ISO 14971:2019, risk management isn't a one-time premarket activity—it's an ongoing process integrated with design controls, biocompatibility evaluation, and quality system operations. For manufacturers navigating regulatory requirements in 2026, effective risk manag

Biocompatibility testing for medical devices has fundamentally changed under ISO 10993-1:2025. The familiar endpoint matrix that automatically prescribed which tests to conduct based on device contact type and duration no longer exists. Instead, manufacturers must conduct systematic biological risk assessment to determine when biocompatibility testing is necessary, which tests are appropriate, and how to justify those decisions scientifically. For medical device manufacturers

Biocompatibility is straightforward at its core: your device materials must not cause an unacceptable biological response in the body under their intended use conditions. In practice, that means you need to understand how your device contacts the body, for how long, what biological hazards exist, and how you'll demonstrate that biological risks are acceptable. What FDA Biocompatibility Requirements Actually Cover FDA uses biocompatibility evaluation to judge whether your devi

ISO 10993-1 sits at the center of how regulators expect you to think about biological safety. It is the international standard for biological evaluation of medical devices, and Part 1 provides the framework for structuring your entire biocompatibility strategy within a risk management process. The 2025 edition, represents the most significant change to biocompatibility evaluation in decades. The familiar endpoint matrix that guided testing decisions for over 30 years has been

Biocompatibility evaluation sits at the intersection of product safety, regulatory compliance, and quality system management. Under the QMSR , which incorporates ISO 13485:2016 by reference, biocompatibility must be fully integrated into your quality management system—not treated as a standalone testing exercise conducted outside your design and risk management processes. The publication of ISO 10993-1:2025 adds complexity and opportunity. The new standard's risk-based biol

As of February 2, 2026, the FDA's Quality Management System Regulation (QMSR) has replaced 21 CFR Part 820 as the foundation for medical device quality systems in the United States. This transition incorporates ISO 13485:2016 by reference, harmonizing U.S. requirements with international quality management standards used by regulatory authorities worldwide. For medical device manufacturers, CROs, and regulatory affairs professionals, understanding what changed is essential fo

Extractables and leachables analysis sits at the core of modern biocompatibility assessment for medical devices. If your device uses polymers, adhesives, colorants, tubing, coatings, or packaging, you are dealing with potential chemical migrants that regulators expect you to understand and control. What Are Extractables and Leachables? Extractables are chemical constituents that move out of a device or material under aggressive laboratory conditions, such as exaggerated temp

Material selection is one of the most critical decisions in medical device design, directly impacting both device performance and patient safety. For design engineers, understanding biocompatibility considerations during material selection can prevent costly redesigns, reduce testing iterations, and accelerate regulatory approval. This guide provides design engineers with practical biocompatibility considerations for selecting materials that meet both functional and biologica

Medical device biocompatibility evaluation is complex, and even experienced manufacturers can make costly mistakes that result in regulatory delays, additional testing requirements, and extended time-to-market. Understanding these common pitfalls can help you avoid them and streamline your path to approval. Based on extensive experience with regulatory submissions, here are the most frequent biocompatibility testing mistakes that cause approval delays—and how to prevent them.

Ensuring a device’s safety for human use demands meticulous planning and thorough analysis, particularly regarding biocompatibility. At...

Biocompatibility test plans are crucial to ensuring that medical devices are safe and compliant for patient use.

Designing, manufacturing, and seeking registration for medical devices requires strict compliance with the set regulations. The...

As it is with every other health product, the quality, safety, and efficacy of a medical device must be built into the product. Achieving...