FMEA for rework reduction in software medical devices-experience

Abstract

Safety and Effectiveness of the product is a crucial part of medical devices as it deals with human lives. In the case of software medical device it is important to establish processes, activities and tasks which assures that the software has been developed in a manner that is likely to produce highly reliable and safe products. It is proven that most of the software failures are design failures and hence the quality and reliability has to be built into the software design for the software medical device. FMEA (Failure Mode and Effect Analysis) is an effective and time-proven tool in the Industry. It is a bottom-up technique that helps in finding opportunities to make the design more robust. An Early Design FMEA (EDFMEA) is an analysis tool used to anticipate and plan actions to resolve potential failure modes as soon as a design concept has begun to be developed. The intention is to be able to influence the design before it has been codified where subsequent changes are more difficult. FMEA is also a good tool in doing hazard analysis for medical devices. It acts as a systematic approach to do evaluation of hazards associated with the medical device by identifying hazards and estimating the risks associated with the device This paper illustrates systematic approach to deploy FMEA in software medical devices through our experience. It also addresses involvement and importance of cross functional team during the design evaluation through FMEA, different challenges that we faced, and how to make a design FMEA successful in reducing the rework and ensuring the Product Reliability.