SEI Safety Assurance Cases for Medical Devices

The Carnegie Mellon Software Engineering Institute performs a number of research projects each year. Their december report on these projects is at the link provided. One of the projects was on safety cases for medical devices. Sherman Eagles of SoftwareCPR and Paul Jones of FDA participated in this project.TECHNICAL REPORT CMU/SEI-2008-TR-025 ESC-TR-2008-025

SEI assurance case work report

SoftwareCPR Training Courses:

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

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