EU MDR Expert Panel Feedback (#5) | MedTech Voices - podcast episode cover

EU MDR Expert Panel Feedback (#5) | MedTech Voices

Jun 28, 2023โ€ข10 minโ€ขTranscript available on Metacast
--:--
--:--
Listen in podcast apps:

Episode description

๐Ÿ—ฃ๏ธ We're excited to release the fifth installment of our MedTech Voices mini series about ๐„๐” ๐Œ๐ƒ๐‘ ๐„๐ฑ๐ฉ๐ž๐ซ๐ญ ๐๐š๐ง๐ž๐ฅ ๐…๐ž๐ž๐๐›๐š๐œ๐ค. If you've been following along, this series is all about sharing perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year.
๐˜๐˜ด ๐˜ต๐˜ฉ๐˜ฆ ๐˜ณ๐˜ฆ๐˜ฑ๐˜ฐ๐˜ณ๐˜ต ๐˜ฅ๐˜ช๐˜ด๐˜ค๐˜ถ๐˜ด๐˜ด๐˜ฆ๐˜ฅ ๐˜ช๐˜ฏ ๐˜ต๐˜ฉ๐˜ช๐˜ด ๐˜ค๐˜ญ๐˜ช๐˜ฑ ๐˜ด๐˜ฆ๐˜ฏ๐˜ฅ๐˜ช๐˜ฏ๐˜จ ๐˜ข ๐˜ฃ๐˜ข๐˜ฅ ๐˜ฎ๐˜ฆ๐˜ด๐˜ด๐˜ข๐˜จ๐˜ฆ ๐˜ต๐˜ฐ ๐˜ฎ๐˜ข๐˜ฏ๐˜ถ๐˜ง๐˜ข๐˜ค๐˜ต๐˜ถ๐˜ณ๐˜ฆ๐˜ณ๐˜ด? ๐Ÿค”
๐Ÿ‘จโ€๐Ÿซย Jaishankar Kutty, Ph.D., VP of Intelligence and Innovation, is joined once more by Medical Director ๐Ÿ‘ฉโ€๐Ÿซย Sally Sennitt. This clip focuses on a transcatheter heart valve โ€“ likely a balloon-expandable valve โ€“ and the report wasn't positive (even troubling). Our experts go into meaningful detail as to why.
Questions covered ๐Ÿ‘‡
1๏ธโƒฃ What was your overall feeling about this one?
2๏ธโƒฃ What were some of your takeaways on the panel's comments and what was submitted to them?
3๏ธโƒฃ What does this mean for manufacturers?
We appreciate you listening!


๐Ÿ“น View and share this clip on LinkedIn.

๐Ÿ“ฒ Follow RQM+ on LinkedIn.

๐Ÿ“š See on-demand content in our Knowledge Center.

๐Ÿ“ 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 โ โ โ โ our contact formโ โ โ โ .