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SEPT IEC 62304 Checklist IEC 62304:2015, Medical Device Software - Software Life Cycle Processes
AAMI TIR48:2015 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
AAMI/IEC TIR80001-2-6:2014 Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-6: Guidance for responsibility agreements
AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities
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