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BS EN ISO 13485:2016

Medical devices. Quality management systems. Requirements for regulatory purposes (British Standard)


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British Standards Institution [BSI]


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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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