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ISO 13485:2016 Standard PDF

& Other Related Standards

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You will need to purchase a copy of the standard to reach certification (sometimes multiple standards are required). Due to copyright restrictions, we are not able to include these with our products. So, we have partnered with Accuris, an authorized seller of ISO Standards. We have sorted each standard into Needed, Recommended, and Additional Related Standards.  Each has a link to purchase through Accuris.

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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