EU MDR Expert Panel Feedback (#11) | MedTech Voices

Device Advice by RQM+

💬 New MedTech Voices Episode: Sally Sennitt and Jaishankar Kutty, Ph.D. dissect the expert panel's review of a groundbreaking extravascular implantable cardiac defibrillator (ICD) and offer insights into regulatory challenges and cardiac care innovation.

Takeaways: 👇

Expert Review Insights for a Novel Extravascular ICD: Get an insider's perspective on the stringent review process by the EU expert panel, including the critical evaluation of safety, efficacy, and novel features of the device.

Data Analysis Deep Dive: Discover the importance of comprehensive data in device approval, from early feasibility studies to pivotal trial results, and how this impacts device certification.

Navigational Guide for Manufacturers: Essential strategies for #MedTech manufacturers on conducting clinical trials, ensuring regulatory compliance, and addressing the expert panel's concerns to accelerate innovation to market.

Future of Cardiac Devices: Engage with these two thought leaders (please ask questions in the comments if you have them!) on the evolution of cardiac care technologies, the role of continuous data assessment, and the significance of post-market surveillance in validating long-term device performance.

There's a ton to unpack in this one and we hope you come away with value after watching! 🙏

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