Medical device Validation/Verification template

Ibomol

Registered
Dear All,

Does anybody have a template or example for verification and validation activities and associated testing plan for 13485 (no software)? The device is a basic stainless steel instrument.

We lack experience in this area and to see an example of how this should be done would be incredibly helpful.

Many thanks,
 

yodon

Leader
Super Moderator
Verification confirms that the device meets all the requirements. What do you do to demonstrate that? Typically includes functional testing, etc.
Validation confirms that the system meets the user needs and intended use. What do you do to demonstrate that? Often includes some kind of clinical assessment, usability studies, etc.

I posted an outline we generally use here: https://elsmar.com/elsmarqualityfor...ification-and-validation-plan-template.75235/
 
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