Medical Devices

A professionally developed, interactive and engaging online training course.

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

ABOUT THE COURSE

This is a professionally developed Medical Device training course which incorporates the Medical Devices Regulation (MDR) implemented in June 2017 with compliance by 2021, along with ISO 14155:2020 and Regulatory guidance from the FDA and MHRA. The Medical Devices Regulation (MDR) supersedes the previous Medical Devices Directive (MDD).

This highly interactive and engaging course enables the learner to develop knowledge and understanding of the Medical Device development process and how to remain compliant with all the relevant Regulations, Guidelines and Standards to gain marketing approval.

It is suitable for anyone currently working on Medical Device Clinical Investigations or those wishing to develop their knowledge, skills and understanding of Medical Devices and how to be compliant with the Regulations, Guidelines and Standards that govern their development

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 chooses to access.

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

Good Clinical Practice Online Courses

Medical Devices

 

£249 (inc VAT)

COURSE CONTENTS

 

Module 1 - What is Medical Devices?
  • What is a Medical Device?
  • Device classification
  • Medical Device Regulators
  • Introduction to Regulations, Guidelines and Standards
Module 2 - Medical Device Regulation
  • Medical Device Regulation (MDR)
  • How is MDR different from MDD?
  • Practical implications of MDR for Sponsors
Module 3 - ISO 14155:2020

ISO 14155:2020:- GCP principles, Informed Consent, Clinical Investigation Planning, structure and content of the Clinical Investigation Plan (CIP), Monitoring Plan, Clinical Investigation conduct, electronic data systems, protecting Medical Devices from cyber-attack, Sponsor, Investigator and Monitor responsibilities, communicating with Ethics Committees and ethical considerations

Module 4 - Gaining Device Approval
  • Gaining Device Approval
  • Investigational Device Exemption (IDE)
  • CE Marking
Module 4 - Course Summary
  • Course Summary
  • Testy Your Understanding Scenarios
  • Test Your Knowledge – Course Exam

"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 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 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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