Project Description


You need this course if you want an overview and an understanding of the intent and the requirements for ISO 13485:2016 Quality Management Systems (QMS).

You will learn how ISO 13485:2016 compatibility with other management systems can affect your organisation and the importance of creating a single quality management system that meets global regulations.


The course intends to cover:

  • the scope and application of the ISO 13485:2016 standard
  • the differences between ISO 13485:2003 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 and how they relate to each other to form a robust effective system
  • how ISO 13485 forms the basis of worldwide Medical Device Regulation
  • the relationship between ISO 13485:2016 and the risk management standard ISO 14971

The course duration will be one day and encompasses a class room style, relevant and engaging exercises supported by comprehensive notes.

Book a Training Course for your Medical Device Regulation

For pricing please send us an enquiry by completing the form and we will get in touch with a quotation