Global Medical Device Podcast Powered By Greenlight.guru

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry.In this episode of the Global Medical Device Podcast, Jon Speer talks to Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. Listen to Allison share her thoughts on what she wishes she had known as an FDA reviewer, providing valuable insights for regulatory professionals in the medical device industry.Some highlights of this episode include:New FDA reviewers are trying to navigate what’s important by asking questions because they have been working from home, never been onsite, and haven’t met their manager or other team members.FDA managers are trying to make sure that their teams get the training and mentorship that they need, but i