FDA Draft Guidance Development Tools Qualification

FDA’s Device Center issued a draft guidance “Medical Device Development Tool”. The direct link is provided. NOTE that this guidance is not for development tools in general. It defines a qualification and FDA submission and determination process for specific types of tools related to clinical and nonclinical evaluation. It provides a mechansim for FDA to essential approve a tool for specific intended use in device evaluation with the intent of streamlining the review process for devices whose performance device was based on tools that were pre-qualified with FDA.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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