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.

Navigating the complex world of medical device biocompatibility can be overwhelming for manufacturers. With stringent regulatory...

When it comes to manufacturing medical devices, ensuring safety and compliance is paramount. Navigating complex regulatory landscapes can...