S5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and Validation

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The Qmed Podcast

Qmed Consulting

45 episodes

8 months ago

Ready to move into the MDR space?

This podcast is for you, if you’re facing challenges within all stages of getting a product to market. To help you we’ve gathered some of the greatest and most influential minds in the Medical Device industry, to get their insights on how to go from an idea to a market success.

You'll be accompanied by our host, Helene Quie, the founder and CEO of Qmed Consulting.

Medicine

Health & Fitness

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Medicine

Health & Fitness

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S5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and Validation

The Qmed Podcast

17 minutes

11 months ago

S5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and Validation

During this session, we will walk through how to translate the requirement specifications into a verification and validation plan, including setting up bio compatibility studies, animal studies and bench test and usability tests, etc. We will discuss how to maintain the traceability from the requirements to verification and validation methods. The importance of design freeze during this process is discussed further.