S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications

08/11/2024 17 min Temporada 5
S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications

Listen "S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications"

Episode Synopsis

Now that you have your user needs description,  we will walk you through how to set the user and device related requirements supported by the list of applicable standards and the device description. Once we have this in place, we will be able to define our clinical claims and clinical and non clinical objectives, Again, we highlight the importance of updating the ongoing documentation throughout the development process.

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