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Introduction

This introductory course provides an overview of ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS) for manufacturers of medical devices.

Who should attend?

  • Individuals, of any level, involved with an ISO 13485:2016 management system who needs an overview of the intent and requirements of the standard
  • Those involved with ISO 13485:2016 who need to create a single Quality Management System.

What will you learn?

  • Scope and application of the new standard
  • The differences between ISO 13485:2003 and ISO 13485:2016
  • Essential definitions and terminology
  • Key requirements of ISO 13485:2016 and how they relate to each other to form a robust, effective system
  • The relationship between the standard and the risk management standard ISO 14971.

What do you need to prepare?

No previous training or knowledge is required to attend this course.

What's included?

  • 7 CPD hours
  • Training course materials
  • Lunch and refreshments for public attendees only
  • Certificate of attendance.

Training from LR

With Lloyd's Register, you can learn in the way that works for you. We offer courses in a range of styles, from in-house to virtual classroom. Find out more about Ascend Training Courses from Lloyd's Register. 

Your future development

Course length

One day.

Certification with Exemplar Global

For an additional $99 USD you can also obtain an Exemplar Global Course Certification for your course.

What are the advantages of adding the Exemplar Global Certification?

With the additional Exemplar Global Course Certification, you will get access to:

  • The Exemplar Global Work Style Behavioural Assessment
  • One-Year Graduate Certification
  • Use of Exemplar Global’s brands and logo to promote your certification
  • Access to Exemplar Global Webinars and Online events
  • Access to Exemplar Global online resources, including Auditor OnLine and regular Job Board notifications
  • Access to the social community of graduates
  • An innovative, continual learning environment for learners and graduates
  • Ongoing support for an entrepreneurial career track for graduates and learners

How to add Exemplar Global Certification to your training course?

If you're booking online, you can add the option of Exemplar Global before you proceed to checkout or contact our team directly.

Find out more

Contact us to learn more about ISO 13485 training.

Book now View dates & locations

Prices from


Course Type

  • In-house
  • eLearning

Course length

In-house

If you are looking for a course for four or more people, you may find our in-house option more cost-effective. Contact the team for a quote.

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