Is it Time to Reevaluate Your Design History File (DHF)?

Standards for reprocessing have been a top priority for regulatory all over the world, and active work around reusable medical devices has challenged medical device firms to think differently from what they’re accustomed to. Updated standards and regulations (MDR, ISO, AAMI) alone are bringing attention to the predicate devices used for submissions for market approval of reusable products.

This 50-minute webinar will help you in considering the question: Will the technological innovations, design, and functional features of these devices bring into question the validity of your design history files (DHFs)?