In-Depth MDR Online Course

Medical Device Regulation (MDR) Foundation Course (EU) 2017/745

Completion time                                    

16 hours                                                     

 

Support period                                     

90 days                                                        

Price

€995 €795* 

*Pre-order discount

Available September 1st

Pre-order now for a 20% discount

 

100% online

with tutor support when you need it

No additional fees

No membership or assessment fees 

We have partnered with Comply Guru, an expert leader in online training to make our MDR course available as an eLearning course.

Course Content

Your course is fully online. 

 

You'll cover 10 units: 

-  Course introduction

-  Introduction to the EU MDR

-  Medical Devices covered by the EU MDR

-  Placing a Device on the Market

-  Device Classification

-  Routes to Conformity

-  GSPR & Risk Management 

-  Clinical Evaluation

-  Technical Documentation 

-  Post Market Surveillance & Vigilance 

______

▪   Learn at your own pace and set your own schedule 

▪   25% off the MDR Guidebook with every enrolment 

▪   Fully certified by Comply Guru and Meddev Solutions

▪   Progress onto the 16-hour EU MDR Foundation Course

▪   Learn practical skills you can implement into your organisation immediately 

 

 

For full details of what you’ll learn, download our course overview.



Assessment


You’ll be assessed through one online multiple choice exam. In order to successfully complete the course, you will need to obtain a grade of 70% or higher. Successful completion will entitle you to receive a certificate of completion.

Entry Requirements 

Working knowledge of medical device quality management systems (QMS) and risk management is recommended prior to completing this course. 

If you don't have this, you can begin with the 2-hour MDR Overview, which has no entry requirements.

 

This course is most suited to individuals who are responsible for or involved with the implementation or maintenance of a medical device QMS, Including but not limited to: 

-  QA Professionals

-  Quality Engineers

-  Research & Design Engineers

-  Internal Auditors

-  Quality Managers

-  Regulatory Professionals

-  Manufacturing Engineers 

Looking for a beginners course? View our 2-hour MDR Overview course

MDR Book

The MDR Guidebook. 

Your 'go-to' reference and tool kit for ensuring MDR compliance.

This guidebook contains a number of useful tools and tables to guide you through the MDR, such as:
 

  • device classification and their differences from the MDD

  • QMS requirements and how they align with ISO 13485

  • technical documentation requirements

  • clinical data requirements, including a handy checklist

  • general safety and performance requirements tables

  • annex and article guide

Receive 25% off with each course enrolment! 

Enrol today →

Make an enquiry below and one of our team will send you more information about the course, answer any questions you have and help you enrol. 

View our other training options →

Address

Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk

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