Wednesday 6th July 2022, 2pm
Risk-based Approaches to Trustworthiness in Medical Devices
Our fieldwork explores the practices surrounding the development and regulation of trustworthy medical devices. Processes in this domain take a risk-based approach that involves tightly defined product specifications, testing, and clinical trial, which is further complemented by quality management procedures throughout the product’s life span. The certified accuracy of a device must be reproducible in manufacture and testing, and sustained in service, meaning that software components, where they exist, are routinely subjected to change-freeze and locked-in to a corresponding hardware specification. Similarly, the safety integrity of a device’s design must also be assured through documented risk-assessment, mitigation, testing, and post-market surveillance and reporting. Our findings reflect on the response of this well-established regulatory approach to the prospective use of medical AI and ‘software as a medical device’, and the implications this has for trustworthiness of autonomous systems in other high-risk domains.