Medical devices

This branch covers regulatory writing for medical devices, divided by the work it serves: market access, clinical investigations, clinical evaluation, post-market surveillance and requirements for particular device types. It leaves medicine documents to medicines, general borderline-product classification to regulatory classification, and the career transition from medicines to moving into device writing.

• Device regulation and market access — definitions, classification, comparisons with medicines and jurisdiction-specific routes and requirements
• Clinical investigations of medical devices — development, investigation planning, connected documents, reporting and registration
• Clinical evaluation of medical devices — evidence, evaluation plans and reports, state of the art, literature, team qualifications, assessment and public summaries
• Post-market surveillance of medical devices — vigilance, recalls, periodic reports, clinical follow-up and real-world evidence
• Devices with requirements of their own — software, connected devices, diagnostics, combination products and animal-tissue devices