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...