FDA Issues Checklist for Standards Conformance

The checklist at the link provided indicates information to be included as part of a pre-market submission when comformance to a standard is claimed as part of the submssion.
This checklist applies to all standards including software standards such as AAMI:SW-68. It indicates that elements of the standard that are not considered applicable be identified along with any deviations from the standard among other information to be provided.

Subscribers to SoftwareCPR.com can get more standards recognition information and a visual aide comparing the different recognized software standards in our library.

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