Medical Devices

Quality Management Systems

A professionally developed, interactive and engaging online training course.

Delivering unique, exciting and interactive e-learning technology courses.

ABOUT THE COURSE

The publication of ISO 13485:2016 marks 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 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 ongoing certification for their organisation.

Finally an online learning platform that’s fun, engaging and can be taken on any device, anywhere, anytime.

HOW LONG
WlLL THE COURSE TAKE?

This course takes approx. 2-3 hrs to complete. This time will vary depending on the user’s previous knowledge and as the course contains lots of links to more information, it will also depend how many the user choose to access.

At the end of the course the user can download and print their own certificate as a record of their course completion.

COURSE CONTENTS

 

Module 1: Introduction 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

I certainly enjoyed using the course and I thought it was easy to use overall. I thought the interactive part of the course and a little tests at the end of each section were especially useful.

Ewelina Testoni, PhD
Training Online 4U
5
2017-12-11T15:31:09+00:00
I certainly enjoyed using the course and I thought it was easy to use overall. I thought the interactive part of the course and a little tests at the end of each section were especially useful. Ewelina Testoni, PhD

"I found the system easy to use and the navigation through various screens was easy too. Varying the way information was accessed and the way the quizzes were done made it more interesting than if it was all the same throughout" 

Veronica
Training Online 4U
5
2017-08-02T14:39:48+01:00
"I found the system easy to use and the navigation through various screens was easy too. Varying the way information was accessed and the way the quizzes were done made it more interesting than if it was all the same throughout"  Veronica

I recommend the online Clinical Research Professionals course to everyone who is thinking of launching their career in clinical research. It is the perfect starting point because it gives you all the necessary basic information presented in a very accessible way, even if you have no preleminary knowledge or are not a native English speaker. The course is well structured and the use of concrete examples makes it easy to grasp the theoretical learning material. In the course you can also find several links to relevant websites which makes it an excellent document to keep for future reference. The user friendly online learning platform completes this pleasant and useful learning experience.

Stefan Smet, Writingale
Training Online 4U
2020-12-18T11:54:18+00:00
I recommend the online Clinical Research Professionals course to everyone who is thinking of launching their career in clinical research. It is the perfect starting point because it gives you all the necessary basic information presented in a very accessible way, even if you have no preleminary knowledge or are not a native English speaker. The course is well structured and the use of concrete examples makes it easy to grasp the theoretical learning material. In the course you can also find several links to relevant websites which makes it an excellent document to keep for future reference. The user friendly online learning platform completes this pleasant and useful learning experience. Stefan Smet, Writingale

I just wanted you to know that I thought the GCP course was good. The right level and I liked the fact you could read more if you wanted to e.g. articles.

Fiona Duthie, PhD
Training Online 4U
2018-03-26T10:49:01+01:00
I just wanted you to know that I thought the GCP course was good. The right level and I liked the fact you could read more if you wanted to e.g. articles. Fiona Duthie, PhD
5
2
Training Online 4U

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Phone

0161 633 4594

Address

82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT

If you prefer to speak to someone call us on 0161 628 9626 and we'll be happy to help.

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