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...