Hardware Podcasts

068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge

Let's Combinate · 18 Jan 2023 · 47m

What this episode covers

David Rutledge, CEO of Global Strategic Solutions and author of 'Mythical Medical', discusses the critical importance of demonstrating product benefit in medical device development, arguing that the industry has historically focused too heavily on risk. He details the role of the Person Responsible for Regulatory Compliance (PRRC) under EU MDR, emphasizing the need for cross-functional teams to define and validate benefits through diverse data sources. Rutledge also shares insights from his book, using narrative characters to illustrate common regulatory pitfalls, audit preparation strategies, and the emotional weight of ensuring patient safety in combination products.

Most relevant to

established companies

Topics

Mentioned

Companies
Global Strategic Solutions, FDA, CDRH, BSI, DEKRA, TÜV SÜD
Products
Mythical Medical
Also
EU MDR

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