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ISO 13485 / ISO 9001 - Medical Devices Quality Management Set
ISO 13485 and ISO 9001
The ISO 13485 / ISO 9001 - Medical Devices Quality Management Set specifies regulatory requirements for a medical device quality management system that can be used by organizations, suppliers and others involved in the various stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing, final decommissioning, and disposal of medical devices. ISO 13485 / ISO 9001 - Medical Devices Quality Management Set includes:
ISO 13485:2016
ISO 9001:2015
ISO 9001:2015/Amd1:2024
ISO 13485:2016 - Medical devices - A practical guide
ISO 13485 / ISO 9001 - Medical Devices Quality Management Set includes:
- ISO 13485:2016
- ISO 13485:2016 - Medical Devices - A Practical Guide
- ISO 9001:2015
- ISO 9001:2015/Amd1:2024
International Organization for Standardization [iso]