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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 13485:2016 - Medical devices - A practical guide

ISO 13485 / ISO 9001 - Medical Devices Quality Management Set includes:


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International Organization for Standardization [ISO]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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