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eCTD 4.0 & Medical Devices: What's Happening in 2025?

EPISODE · Feb 13, 2025 · 16 MIN

eCTD 4.0 & Medical Devices: What's Happening in 2025?

from Ennovation Podcast · host Ennov

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager.  We discuss the latest eCTD 4.0 news and a recent MHRA consultation on Medical Devices. Know what’s coming, when. Check out our eCTD 4.0 implementation timeline Be part of the future of publishing. Download Diarmuid’s pilot readiness checklist Get prepared. Catch up on the MHRA’s proposals Is your RIM system built for Medical Devices? Navigate MDR/IVDR and UDI with ease with Ennov RIM

What this episode covers

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I'm joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager. We discuss the latest eCTD 4.0 news and a recent MHRA consultation on Medical Devices. * Know what's coming, when. Check out our eCTD 4.0 implementation timeline [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-timeline/] * Be part of the future of publishing. Download Diarmuid's pilot readiness checklist [https://en.ennov.com/insider/regulatory/ectd-4-0-pilot-readiness-checklist/] * Get prepared. Catch up on the MHRA's proposals [https://en.ennov.com/blog/mhra-medical-devices-in-vitro-diagnostics/] * Is your RIM system built for Medical Devices? Navigate MDR/IVDR and UDI with ease with Ennov RIM [https://en.ennov.com/insider/regulatory/compliance-without-compromise-med-device/]

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eCTD 4.0 & Medical Devices: What's Happening in 2025?

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This episode was published on February 13, 2025.

What is this episode about?

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager. We...

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