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ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package

ANSI/AAMI/ISO 13485, ANSI/AAMI/IEC 62304 and ANSI/AAMI/ISO 14971 - Software, Quality and Risk Management of Medical Devices

The ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software. The ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes:

 
     
  • ANSI/AAMI/IEC 62304:2006
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  • ANSI/AAMI/IEC 62304:2006/A1:2016
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  • ANSI/AAMI/ISO 14971:2007 (R2016)
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  • ANSI/AAMI/ISO 13485:2016
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ANSI/AAMI/ISO 13485 / ANSI/AAMI/IEC 62304 / ANSI/AAMI/ISO 14971 - Medical Devices Package includes:

Content Provider
Association for the Advancement of Medical Instrumentation [AAMI]


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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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