A 45 page 483 for the American Red Cross Biomedical Headquarters. Many of the observations are computer-related although it is not always clear if the issues are with medical devices, validation, or Blood Establishment procedures and use error.
A 45 page 483 for the American Red Cross Biomedical Headquarters. Many of the observations are computer-related although it is not always clear if the issues are with medical devices, validation, or Blood Establishment procedures and use error.
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.