Guide to the development and inclusion of aspects of safety in international standards for medical devices

Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale

Medical devices – Quality management systems – Requirements for regulatory purposes

Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

Medical devices – Quality management systems – Requirements for regulatory purposes

Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances

Medical vehicles and their equipment – Air ambulances – Part 2: Operational and technical requirements for air ambulances

Medical device traceability enabled by unique device identification (UDI)

Medical devices – Application of risk management to medical devices (ISO 14971:2019)

Medical devices – Application of risk management to medical devices