Global Medical Device Podcast Powered By Greenlight.guru

Description:Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA. They reveal insights that every MedTech professional must know, breaking down the philosophy, challenges, and expectations surrounding inspections, all while blending unique "Mike Drues isms" and Etienne's candid takes.Some of the highlights of this episode include:Grasping the art of proactive communication with the FDA, laying the foundation for regulatory success.Delving into the essence of managing FDA's expectations during pivotal conversations.Exploring the unpredictability of FDA inspections and the mantra of always being prepared.Differentiating between inspections for class two/lower medical devices and class three devices.Unpacking the role of FDA registration in attracting the FDA's attention for inspections.Achieving the perf