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Towards an Assurance Case Practice for Medical Devices

October 2009 Technical Note
Charles B. Weinstock, John B. Goodenough

In this report, the authors explore how to enable manufacturers and federal regulators gain confidence in software-dominated medical devices.

Publisher:

Software Engineering Institute

CMU/SEI Report Number

CMU/SEI-2009-TN-018

Abstract

Software technology enables an increasing percentage of medical device functionality, leading to much more complex systems and presenting a challenge to regulators charged with evaluating device safety and effectiveness. An approach to evaluating claims of safety increasingly used in Europe and elsewhere is the safety assurance case. Much like a legal case, the assurance case lays out an argument and supporting evidence to show that safety claims are valid.

This technical note explores the use of assurance cases for justifying claims of medical device safety. It illustrates the use of the assurance case on a particular type of medical device—the infusion pump. This example serves as a basis for discussing issues surrounding the introduction of assurance cases into the medical device community, which includes both manufacturers and the U.S. Food and Drug Administration.