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ISO 13485 / ISO 19011 - Medical Devices Regulatory Package

ISO 13485 / ISO 19011 - Medical Devices Regulatory Package (Save 10% off List Prices)

The ISO 13485 / ISO 19011 - Medical Devices Regulatory Package provides regulatory requirements for a medical devices quality management system. It is also supported with guidance on auditing a management system including the principles of auditing, managing an audit program and conducting management system audits.

ISO 13485 / ISO 19011 - Medical Devices Regulatory Package 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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