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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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