FDA Standards Recognition and USe Guidance

FDA updated its guidance related to standards recognition on 17-Sep-2007. The full document is at the link provided. It describes requirements for the declaration of conformity description and discusses documentation required and limitations of use of consensus standards. This is relevant for use of software standards such as ISO 62304 as well as all other relevant standards.

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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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