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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.