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BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package

BS EN ISO 13485 and BS EN ISO 14971 (British Standard)

The BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management 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. The BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package includes:

 
  • BS EN ISO 13485:2016
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  • BS EN ISO 14971:2012

BS EN ISO 13485 / BS EN ISO 14971 - Risk and Quality Management Medical Devices Package includes:

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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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