A new draft of the international “Medical device software – Software life-cycle processes” has been released for comments. This standard is based on the ANSI/AAMI U.S. national standard SW68 which it is intended to replace. The comment period ends April 30, 2004 and the draft 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
Or just email training@softwarecpr.com for more info.
