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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 and A1:2016
- ANSI/AAMI/ISO 14971:2019
- ANSI/AAMI/ISO 13485:2016 (R2019)
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]
