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

Abstract

Abstract. Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the medical device software development and maintenance lifecycles is an important part of demonstrating that 'safe' software has been produced through adopting defined processes. Consequently, medical device standards and guidelines emphasise the need for traceability. This paper outlines the extent and diversity of traceability requirements within medical device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the findings obtained when a lightweight assessment method (MedTrace), that we created, based upon the traceability practices within these standards, was implemented in two SME organisations. Finally we highlight how the findings indicate a lack of guidance as to what is required when implementing and maintaining a traceability process.

Process improvement approaches fertilised by advances in SPI

“…‘Development of MDevSPICE® ‐ the Medical Device Software Process Assessment Framework’ by Lepmets et al is presenting the integration of medical standards and guidance documents with software development best practices. Software development in the medical domain is one of the hot topics in the community including lifecycle models , process communication , and traceability assessment citing the most relevant and recent cases.…”

“…The paper entitled ‘Assessing Traceability – Practical Experiences and Lessons Learned’ is authored by Regan et al In this case, traceability is also one of the topics previously covered by EuroSPI authors, including efforts on requirements for traceability and traceability assessment methods , citing just two of the most recent examples.…”

An analysis of safety evidence management with the Structured Assurance Case Metamodel

“…If someone thinks of for example an architecture model as an exhibit, such a model could be specified in several electronic sources (files) representing different architectural views. The support to the specification of further types of relationships is especially important because of the major role of traceability in the assurance and certification of safety-critical systems [42]. The Document Properties class diagram (Fig.…”

Research findings from an industrial trial of a traceability assessment and implementation framework

“…The framework consists of a traceability assessment model (TAM) and a traceability roadmap (TR). The TAM identifies any gaps in an organizations implementation of traceability best practices [18] and/or medical device standards' traceability requirements [19], and the TR provides the pathway for an organization to plug those gaps. An initial validation of the TAIF was completed through expert review [15,16].…”