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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 interactive and highly engaging online course has been re-designed to provide an 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 including scenarios and regular knowledge checks. 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 on-going certification for their organisation.
- QMS information leaflet - download
Module 1- Intro to ISO 13485
What is a Medical Device?
Introduction to ISO 13485
Scope of ISO 13485
Key improvements from the 2003 version of the Standard
Module 2- Quality Management Systems (QMS)
QMS general requirements
What is an ISO 13485 compliant QMS?
QMS document requirements
Module 3- ISO 13485 practical implications
Measurement, analysis and improvement
Module 4- Summary
Knowledge consolidation- scenario
Knowledge check- exam
Who is this course for?
Explore the requirements of ISO 13485:2016 and how to apply this Standard in your own organisation. This course is suitable for anyone working in any phase of the Medical Device development life-cycle.
On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant Quality Management System and help maintain on going certification for their organisation.
Questions and answers
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