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Human factors in the design of medical devices – approaches to meeting international standards in the European Union and USA

This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were anal...

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Bibliographic Details
Main Authors: Mary Privitera, Mark Evans, Darren Southee
Format: Default Article
Published: 2017
Subjects:
Online Access:https://hdl.handle.net/2134/22726
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