The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of confusion.In this episode, Michelle Lott joins Etienne Nichols (Greenlight Guru) and Karandeep Singh Badwal to debate the real-world impact of MDR on medtech innovation, market access, and patient safety.From notified body bottlenecks to language barriers, inconsistent interpretations, and the myth of increased safety, the trio unpacks what MDR is really doing to the industry — and what manufacturers can do to survive (and thrive) under it.Here's what you’ll learn:How MDR differs from MDD — and why it’s not a total overhaulWhy software, AI, and post-market surveillance have become regulatory pain pointsThe 12–18 month reality of CE marking under MDRHow to select the right notified body (and why language matters)Why documentation ≠ device safety — and integrity still matters mostThe “significant change” rule: what triggers recertificationWhy smaller companies are struggling to stay in the EU marketPractical steps to build a quality culture and navigate MDR effectivelySubscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.Watch the video on YouTube: https://youtu.be/Kgbmh0neJpEVisit us at https://leanraqa.com/ for even moreregulatory goodness and to learn more about our services.

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