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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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