Envisioning a requirements specification template for medical device software

Abstract

In many health jurisdictions, software is considered to be medical device software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient’s health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a medical device. Flaws inMDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of medical device software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a ‘good’ MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.