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

Human factors/ergonomics to support the design and testing of rapidly manufactured ventilators in the UK during the COVID-19 pandemic.

BACKGROUND This paper describes a rapid response project from the Chartered Institute of Ergonomics & Human Factors (CIEHF) to support the design, development, usability testing and operation of new ventilators as part of the UK response during the COVID-19 pandemic. METHOD A five-step approach was taken to (1) assess the COVID-19 situation and decide to formulate a response; (2) mobilise and coordinate Human Factors/Ergonomics (HFE) specialists; (3) ideate, with HFE specialists collaborating to identify, analyse the issues and opportunities, and develop strategies, plans and processes; (4) generate outputs and solutions; and (5) respond to the COVID-19 situation via targeted support and guidance. RESULTS The response for the rapidly manufactured ventilator systems (RMVS) has been used to influence both strategy and practice to address concerns about changing safety standards and the detailed design procedure with RMVS manufacturers. CONCLUSION The documents are part of a wider collection of HFE advice which is available on the CIEHF COVID-19 website (https://covid19.ergonomics.org.uk/)