FMEA for rework reduction in medical device software-experience

Safety and Effectiveness of the product is crucial part of medical devices as it deals with human lives. In the case of medical device software it is important to establish processes, activities and tasks which assure 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 medical device software.