A proposal for a guidance document on “Applying the Quality System to Medical Device Data Systems” has been submitted to AAMI by the FDA. The work is expected to be done by the AAMI software committee and the AAMI Quality Management committee.
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.