FDA published its Final Universal Device Identification Rule This includes that standalone software need only provide a means to display a human readable UDI. The full link to FDA’s web page on the UDI rule is at the link provided.
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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