Medical Devices – Quality Management Systems

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The publication of ISO 13485:2016 marked a turning point in Quality Management Systems for those involved in the lifecycles of Medical Devices.

ISO 13485:2016 was written to support Medical Device manufacturers in designing Quality Management Systems (QMS) that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of Medical Devices that are safe for their intended purpose. ISO 13485 was last reviewed in 2020, which maintained that the 2016 version was still current.

This professionally developed, interactive and highly engaging online course has been re-designed in 2020 to provide in-depth understanding of ISO 13485:2016 and its practical implications. Learners will discover new knowledge and skills through a range of interactive learning methods.

On completion of this training, participants will be able to apply their knowledge to the development of an ISO 13485:2016-compliant Quality Management System and help maintain ongoing certification for their organisation.


Learning Objectives

  • Understand the scope of ISO 13485
  • Consider what makes an effective QMS
  • Understand what makes an ISO 13485 compliant QMS
  • Learn the documentation requirements for an ISO 13485 QMS
  • Examine the practical implications of ISO 13485 for an organisation
  • Consider how to apply ISO 13485 to individual organisations and become compliant in the Standard.


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