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ISO 13485:2016 Medical devices — Quality management systems —

Requirements for regulatory purposes

ISO 13485:2016 specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing, final decommissioning, disposal of medical devices.

ISO 13485:2016 can also be used by suppliers or other external parties providing product like raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform.