What makes a successful regulatory submission from a clinical trial perspective for IVDs? – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.*

🎯 𝗪𝗵𝗮𝘁 𝗺𝗮𝗸𝗲𝘀 𝗮 𝘀𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗳𝗿𝗼𝗺 𝗮 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗽𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲 𝗳𝗼𝗿 𝗜𝗩𝗗𝘀?

Did you know 60-80% of IVD 510(k)s require clinical data?

In this must-watch video, Director of IVD Global Regulatory Affairs Margot Borgel, Ph.D. is joined by Nancy Morrison, RAC (with 30+ years of regulatory experience) and they break down the make-or-break factors in IVD submissions.

𝗞𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀:

– Why clinical data is non-negotiable for modern IVD submissions

– Critical FDA & EU regulatory expectations for clinical evidence

– How to avoid costly study design mistakes

– Smart strategies for patient population selection

– Key considerations for diversity in clinical trials

– Tips for navigating the IVDR transition period

𝗕𝗼𝗻𝘂𝘀 𝗜𝗻𝘀𝗶𝗴𝗵𝘁: Learn why "baby steps" in regulatory strategy might actually 𝘨𝘦𝘵 𝘺𝘰𝘶 𝘵𝘰 𝘮𝘢𝘳𝘬𝘦𝘵 𝘧𝘢𝘴𝘵𝘦𝘳!

Don't miss this expert guidance on avoiding the pitfalls that could force you to restart your entire clinical program.

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