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Guide to the development and inclusion of aspects of safety in international standards for medical devices
Information supplied by the manufacturer of medical devices
Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards:
Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
Medical devices – Quality management systems – Requirements for regulatory purposes
CE Harmonized
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
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