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June 7, 2015
FDA issued a final version of its Universal Device Identification rule in 2013 and this rule is posted in the softwarecpr.com library. FDA also created and updates a webpage devoted to implementation of this rule (which will take place over seven years with higher risk devices sooner and lower risk devices at the end).
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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

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