FDA Premarket Approval (PMA) Web Page

The prior PMA manual was obsoleted by FDA and FDA indicated it is best to refer to their PMA web pages for current information. Note this is for PMAs not 510(k)s or other forms of premarket submission.

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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