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Device History Record

White Paper: Device History Records – What Should They Include?

The FDA requires the use of DHRs for Medical Device manufacturing. ISO 13485:2016 does not specify a “DHR” requirement; however, it does identify similar requirements for the establishment and maintenance of manufacturing records. As applicable, it is possible to create a system with contents that address the requirements of FDA as well as ISO, in a single DHR format.

 

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