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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 14971:2019
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  • ANSI/AAMI/ISO 13485:2016 (R2019)
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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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