Changes in FDA Registration and Listing FAQ

FDA issued a summary of changes to device registration and lising effective Oct 1, 2012 along with answers to frequently asked questions. This is available at the link provided.

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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