Episode 1 - Regulatory
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Episode 1 - Regulatory
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このコンテンツについて
Ever wondered why some medical devices make it to market while others disappear into oblivion? Why some "game changing" innovations take years or decades to get approved? It all comes down to one often misunderstood word: Regulatory.
In this episode, we dive into the real story behind regulatory affairs with Christine Scifert, Partner at MRC Global, and Al Nanni, Founder of North MedTech Advisors and Pivot Med Tech. From navigating the FDA’s complex approval process to debunking myths about product clearances, this conversation reveals why regulation isn't just red tape—it's the invisible force shaping much of the MedTech industry.
Whether you're in sales, product development, or just curious how medical devices really works, this episode will change how you view every medical device you touch.
Listen now and learn how the rules explain why things are the way they are!