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

29/11/2024 17 min Temporada 5 Episodio 6
S5 E6: Academy Talks: Medical Device Documentation: Pre-clinical testing, Verification and Validation

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Episode Synopsis

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.

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