Comments Requested on FDA Software Guidances

The AAMI software committee is preparing comments on the “FDA Guidance for the Content of Premarket submissions for Software Contained in Medical Devices” in the interest of providing FDA input for future revision of this and related guidances. If you are not a member of the AAMI software committee and would like SoftwareCPR (a member of AAMI with representation on several working groups) to incorporate your comments for review by the committee you can send them to our Managing Partner at alan@softwarecpr.com.

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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