Assesses software products to determine whether they meet the criteria for classification as Software as a Medical Device (SaMD). Conducts hazard identification and risk assessments in accordance with ISO 14971. Produces and maintains documentation to demonstrate compliance with the UK Medical Device Regulation (MDR), including the creation and maintenance of the Risk Management File and supports the regulatory lead in the production and ongoing integrity of the technical file and Quality Management System. Manages updates to documentation and safety cases throughout the device lifecycle, ensuring post-market surveillance, incident reporting and change control processes are embedded to maintain ongoing regulatory compliance.