Abstract
To meet the FDA's Quality System Regulation, medical device manufacturers must include design validation as part of their design and development activities. However, the regulation does not specify which product requirements must be validated or what methods satisfy a proper design validation process. This paper outlines an approach that device manufacturers can follow to determine which product requirements should undergo design validation testing and what types of testing methods should be used.
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More From: Proceedings of the Human Factors and Ergonomics Society Annual Meeting
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