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ISO 14971/Amd1:2003

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements


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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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