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DS/EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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Danish Standards [ds]



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CAN/CSA ISO 9000-16 (R2020)

Quality management systems - Fundamentals and vocabulary (Adopted ISO 9000:2015, fourth edition, 2015-09-15)

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CSA America, Inc. [csa]



Most Recent

DS/EN ISO 13485:2016/AC:2018

Medical devices - Quality management systems - Requirements for regulatory purposes

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Danish Standards [ds]



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DS/EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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Danish Standards [ds]



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ISO 10007:2017

Quality management - Guidelines for configuration management

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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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