In-Depth MDR Online eLearning Course

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

Completion time                                    

16 hours                                                     

 

Support period                                     

90 days                                                        

Price

€995

Available September 1st

Pre-order now!

 

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

This fully online EU MDR training course is the most comprehensive, self-paced course available on the EU Medical Device Regulation (MDR) and offers both an industry and notified body insight with practical examples throughout. 

 

This course provides you with full flexibility to learn at your own pace and in your own time.

In this course, you'll cover 9 units: 

Unit 1: Introduction to the EU MDR

▪   History of the EU-MDR

▪   Purpose of the EU-MDR

▪   Structure of EU-MDR

▪   Key Terminology

▪   Key EU-MDR changes

▪   EU-MDR Timelines for transition

Unit 2: Medical devices covered by EU-MDR

▪   What is a device?

▪   Devices in scope

▪   Devices out of scope

▪   Non-Medical devices

Unit 3: Placing a Device on the Market

▪   Overview of Chapter II

▪   Articles 5-9

▪   Economic Operator & PRRC Responsibilities

▪   Articles 16-24

Unit 4: Device Classification

▪   Overview of Annex VIII

▪   Class Types

▪   Classification Rules

Unit 5: Routes To Conformity

▪   Overview of Conformity Annexes

▪   Annex IX

▪   Annex X

▪   Annex XI

▪   Custom Made Devices

▪   Notified Body Articles & Annexes

Unit 6: GSPR & Risk Management 

▪   Overview of Annex I

▪   Chapter I General Requirements

▪   Risk Management 

▪   Chapter III Device Information

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 

Unit 7: Clinical Evaluation

▪   Overview of the Clinical Evaluation   requirements including Article 61-62 and Annex XIV

Unit 8: Technical Documentation 

▪   Overview of Annex II & III

▪   Contents of Technical Documentation

▪   Device Description

▪   Labelling

▪   Manufacturing

▪   GSPR

▪   Risk

▪   Verification & Validation

Unit 9: Post Market Surveillance & Vigilance

▪   Overview of PMS Articles 83-86

▪   Overview of Vigilance Articles 87-89

Pre-Order today →

Enquire today and one of our team will send you more information about the course, answer any questions you may 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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