The Global Harmonization Task Force revision of its guidance on Essential Principles of Safety and Performance of Medical Devices is at the link provided. GHTF Essential Principles. It includes requirements for software that are similar to the European Union’s essential requirements relating to software.
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.
