Digital risk assessment for medical technology

PI: Bergmann, Jeroen

Department: Engineering Science (DF)

In my computer science DPhil, I utilised open data from regulators to manage security, privacy, and safety risks in information systems. For this application, I will apply my DPhil research to the field of online support for medical device development. Determining the risk that medical devices pose to patients is important from a general safety point of view. Manufacturers of these devices need to assess the inherent risks in their devices and develop an effective management plan to address them. The company RegMetrics has developed an online platform that helps people navigate the medical device regulations. This project will explore the integration of my research on machine learning approaches to regulatory compliance into the existing RegMetrics platform to make it available to users. The project will assess the effectiveness and usability of these novel approaches through stakeholder engagement and feedback.