Medical Device Software Traceability

Abstract

Software traceability is central to medical device software development 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 demonstrate how they follow a software development lifecycle without mandating a particular 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 describes the development and implementation of a medical device traceability software process assessment method (Med-Trace) in two medical device software development 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.

Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

“…A sample of the scripted MED-TRACE questions along with their source are listed in Table 4. For a greater sample of these questions the reader is referred to book chapter [21]. How is traceability undertaken from the software related hazards and the software risk control measures to the corresponding safety-related software requirements and the software items that satisfy those requirements?…”

“…Traceability was initially used to trace requirements from their source to implementation and test, but now plays an increasing role in defect management, change management and project management. Increasingly software development is globally distributed across multiple teams and sites which makes traceability even more important [21]. As traceability provides an essential support for developing high quality software systems [22], it is vital to engage an efficient traceability process.…”

“…Defective medical device software can cause serious injury or death. Therefore safety is a key concern [21]. In the period from 7 th Feb 2011 and 7 th Feb 2012 the FDA recorded 151 medical device recalls and state software as the cause [26].…”

“…At the heart of such processes, they must incorporate traceability. Generally there is a lack of published material regarding traceability in medical device software in addition to a lack of guidance on how to implement traceability effectively in recognisations [21]. As traceability is central to the development of medical device software, a traceability assessment and improvement method called MedTrace [23] has been developed (See section 5).…”

Traceability-Why Do It?

“…Traceability was initially used to trace requirements from their source to implementation and test, but now plays an increasing role in defect management, change management and project management. Increasingly software development is globally distributed across multiple teams and sites which makes traceability even more relevant [3]. Good traceability information is also important to process improvement.…”