Global Medical Device Podcast Powered By Greenlight.guru

In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development. They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in the U.S., the effects on clinical trials, AI-driven digital evidence, and what companies must do to stay compliant and innovative in a volatile regulatory environment.Key Timestamps:[02:30] – Introduction to Sarah Moeller and her role in ISO 18969 updates.[07:00] – Overview of ISO standards update processes and FDA’s critical role.[15:20] – The impact of AI and digital evidence on clinical evaluations.[22:10] – Why FDA's temporary absence from standards writing matters.[31:45] – Resumed communications: FDA’s current engagement status.[41:00] – Implications of leadership changes at t