Medical Devices Quality Management Systems

This interactive an engaging online course has been designed to provide an in depth understanding of ISO 13485:2016.

Trainingonline4U Ltd


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£220 inc VAT (was £299)
Or £73.33/mo. for 3 months... Read more
Offer ends 14 April 2021
Study method
Online, self-paced
3 hours
Access to content
90 days
No formal qualification
3 CPD hours / points
Additional info
  • Certificate of completion available and is included in the price

3 students purchased this course

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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.


3 CPD hours / points
Accredited by The CPD Certification Service

Course media



Course Contents:

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

Management responsibilities

Resource management

Product realisation

Measurement, analysis and improvement

Module 4- Summary

Course 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.

Career path

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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What does study method mean?

Study method describes the format in which the course will be delivered. At courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

What are CPD hours/points?

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on, many of which can be completed online.

What is a ‘regulated qualification’?

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

What is an ‘endorsed’ course?

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body’s logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.


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