What are the requirements of ISO 13485?

Application of ISO 13485 requirements
  • This International Standard specifies the requirements for a quality management system that can be used by organizations involved in one or more stages of the life cycle of a medical device, including the design and development, manufacture, storage and distribution, installation, maintenance, decommissioning and disposal of medical devices and related creating or providing activities (such as technical support).
  • The requirements specified in this International Standard may also apply to suppliers or external parties providing products (e.g. raw materials, parts, assemblies, medical devices, sterilization services, calibration services, distribution services and maintenance services) to the above organizations.
  • In Europe, EN ISO 13485:2016 is harmonized with the European Medical Regulation. In this way, the ISO 13485 certificate becomes especially important for obtaining the right to label medical products with the CE mark.

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