Episode description

🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are starting off this week with plenty of good things to say in a new MedTech Voices video.

This time, they unpack the EU MDR expert panel's evaluation of a novel resorbable device aimed at revolutionizing hernia repair procedures.

Why watch (or listen) 👇

🔍 Scrutinizing the Longevity of Resorbable Devices:
Understand the balance between durability and resorption rates in implantable devices and why this matters for patient outcomes.

🌐 Exploring the Interplay of Device Design and Clinical Trials:
Discover the implications of a device’s material composition, such as P4HB and PGA, on its performance and the intricacies of clinical trial design that capture this data effectively.

🔬 Data Assessment Through an Expert Lens:
Learn how the expert panel dissect presented data — from safety to performance — and the significance of stratification in clinical evidence for specific surgical applications.

📊 Emphasizing Post-Market Surveillance:
Explore the crucial role of post-market clinical follow-up (PMCF) plans and how they contribute to understanding the long-term impact of medical devices.

📝 Critical Analysis of Notified Body and Manufacturer Data:
Hear how a well-conducted review can influence the perception of a device's safety and performance, and what the consensus from an expert panel signifies for the future of device approval.

As always, if you have any feedback or questions we hope you'll let us know! 🙏

-

📹 ⁠⁠⁠⁠View and share this clip on LinkedIn.⁠⁠⁠⁠

📲 ⁠⁠⁠⁠Follow RQM+ on LinkedIn.⁠⁠⁠⁠

📚 ⁠⁠⁠⁠See on-demand content in our Knowledge Center.⁠⁠⁠⁠

📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use ⁠⁠⁠⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠⁠⁠⁠.