SFIA Skills: Risk management (BURM)

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.

Plans and manages the implementation of organisation-wide processes and procedures, tools and techniques for clinical risk management associated with digital systems. Manages clinical safety risk assessment activities within the organisation. Develops clinical risk management processes and procedures, and identifies and deploys appropriate tools and techniques (e.g. SWIFT, FMEA).

Appraises patient safety risk in the procurement, design, development, deployment and decommissioning of information systems and technologies and ensures that all risk is assessed and managed appropriately to minimise or avoid harm.

Plans and manages the implementation of organisation-wide processes and procedures, tools and techniques for the identification, assessment, and management of clinical risk inherent in the operation of processes and of potential risks arising from planned IT-enabled change.

Provides clinical safety leadership across the organisation, guiding the development and implementation of clinical risk management strategies. Advises on the design and operation of the organisation-wide clinical risk management system.