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ISO 13485 / 14971 / 14969 - Medical Devices Package

ISO 13485 / 14971 / 14969 - Medical Devices Package

The ISO 13485 / 14971 / 14969 - Medical Devices Package provides regulatory requirements for quality management medical device systems and incorporating and maintaining a risk management system accociated with the use of medical devices. This package includes:
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO 14971:2007
ISO/DIS 14971:2018
ISO/TR 14969:2004 Historical Document

ISO 13485 / 14971 / 14969 - Medical Devices Package includes:

Content Provider
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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