SEI Safety Assurance Case Medical Device Example

The Carnegie Mellon Software Engineering Institute continued work on safety assurance cases for medical devices by publishing a paper entitled “Towards an Assurance Case Practice for Medical Devices” doing an example case for an infusion pump. The full article is at the link provided. Although this is intended uses infusion pumps as an example it is intended to present concepts useful for many devices.

The full paper can be viewed here: Towards an Assurance Case Practice for Medical Devices

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

Or just email training@softwarecpr.com for more info.

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