Medical device software traceability.

Software traceability is central to medical device software develop-ment and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have clear linkages and traceability from requirements - including risks - through the different stages of the software development and maintenance lifecycles. The regulatory bodies request that medical device software development organizations clearly demon-strate how they follow a software development lifecycle without mandating a par-ticular lifecycle. However, due to the traceability requirements of the industry most medical device companies adopt the V-model. Within this chapter we will discuss the importance of traceability to medical device software development, the current state of practice within the industry in relation to traceability and how we feel that traceability could be improved within the industry. The chapter also de-scribes the development and implementation of a medical device traceability soft-ware process assessment method (Med-Trace) in two medical device software de-velopment organizations. We include these two case studies as one involved a medical device SME based in Ireland and the other a medical device SME based in the UK as we want to illustrate that Med-Trace can be applied within different countries.