ISO 13485:2016 Appreciation and Interpretation

Medical Devices Monitor ImageISO 13485:2016 Appreciation and Interpretation
One Day 

You need this course if ...

  • You want an overview and an understanding of the intent and requirements of ISO 13485:2016 quality management systems (QMS)
  • You need to understand ISO 13485:2016 compatibility with other management systems
  • You want to convert from ISO 9001 to ISO 13485:2016
  • If you want to to create a single quality system that meets global regulations

You will learn …

  • The scope and application of the ISO 13485:2016 standard
  • The differences between ISO 13485:2003 and EN ISO 13485:2012 and ISO 13485:2016
  • Essential definitions and terminology to help you interpret and apply ISO 13485:2016 requirements
  • The key requirements of ISO 13485:2016 Medical Devices and how they relate to each other to form a robust effective system
  • How ISO 13485 forms the basis of worldwide Medical Device Regulation with particular emphasis on Canadian Regulation CMDCAS
  • The relationship and differences between ISO 13485:2016 and ISO 9001:2015 requirements
  • The relationship between ISO 13485:2016 and risk management standard ISO 14971

You will need …

  • No previous training

Your future development

Course length

  • One day

Contact us to learn more about ISO 13485:2016 training

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