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ISO 13485:2016 Standard PDF

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Needed for ISO 13485 Certification:

Graphic of the ISO 13485:2016 Quality Management System Standard
ISO 13485:2016 –Medical devices – Quality management systems – Requirements for regulatory purposes

ISO 14971:2019– Medical devices – Application of risk management to medical devices

Additional Related Standards:

ISO 9001 Family
  • ISO 9000:2015 – Quality Management Systems – Fundamentals and Vocabulary
  • ISO 9001:2015 – Quality Management Systems – Requirements
  • ISO 9002:2016 – Guidelines for the application of ISO 9001:2015
  • ISO 9004:2018 – Quality Management – Quality of an organization – Guidance to achieve sustained success 
Medical Device Software
  • IEC 62304 Ed. 1.1 b:2015 – Medical device software – Software life cycle processes – Consolidated Edition
  • IEC/TR 80002-1 2009 – Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
  • ISO/TR 80002-2:2017 – Medical device software – Part 2: Validation of software for medical device quality systems
  • ISO 31000:2018 – Risk Management Guidelines
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