Live! #73 – October Overview: Essential Insights from an Eventful Month in MedTech

Device Advice by RQM+

This show was recorded 26 October 2023 and can be viewed on our website ⁠⁠⁠here⁠⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏

Listen in as Boston Scientific's Sr. Global Regulatory Intelligence & Advocacy Manager joined RQM+ experts for a special edition of our Live! show, all about the month's industry events! This session brings together insights from an array of events our team attended throughout October, such as the RAPS Convergence and The MedTech Conference (AdvaMed). We've soaked in knowledge, experiences, and taken note of industry updates. Now, we're excited to come together and share the crux of what we've discovered — the revelations, shifts, and noteworthy advancements.

We'll touch upon:

• Key topics from a broad spectrum of events
• Crucial shifts in industry practices and guidelines
• Overarching themes that resonated across various conferences
• Answering questions and providing clarity on intricate topics

Whether you attended any of the October events or not, this session is a golden opportunity to gain a consolidated perspective of the busiest month in MedTech and draw connections between different events.

Panelists:

• Olga van Grol-Lawlor – Sr. Global Regulatory Intelligence & Advocacy Manager, Boston Scientific
• Amie Smirthwaite, Ph.D. – Sr. VP of Intelligence & Innovation, RQM+
• Nancy Morrison, RAC – Vice President, Intelligence & Innovation, RQM+ (moderator as well)
• Dirk Steenmans – Global Head, Clinical and Post-Market Practice, RQM+

Timestamps:

• 4:11 -- What events did everyone attend and what was your role in those events?
• 8:19 -- Were there any trends you saw across conferences or that applied around the world?
• 21:07 -- It's understood that manufacturers are unhappy about the MDR, but precisely what aspects of the MDR are causing problems?
• 33:02 -- What was the most debated or discussed session at any of the conferences?
• 41:59 -- How do I find SSCPs posted on EUDAMED?
• 42:33 -- How complete is real-world evidence? What about the use of registries? What's the data being collected? (Amie's "IT DEPENDS" sign makes its first appearance!)
• 50:38 -- What is the latest on post-market surveillance? When can I stop doing PMCF? Do I need a WET device?
• 57:24 -- What are you most hopeful about?

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