The link provided is a position paper on: Risk in Medical Devices. It discusses the unique aspects of risk versus benefits to be addressed in medical device risk management. It proposes a framework for consideration.
The link provided is a position paper on: Risk in Medical Devices. It discusses the unique aspects of risk versus benefits to be addressed in medical device risk management. It proposes a framework for consideration.
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.