Medical Device Regulation (EU MDR) 2017/745

VIRTUAL CLASSROOMS

Course Overview

 

The Medical Devices Regulation (EU 2017/745) has replaced the Medical Devices Directive (93/42/EEC) as the legislation detailing the requirements that manufacturers must comply with in order to place medical devices on the market within the European Union.

Our two day online instructor-led MDR training course has been created to help medical device manufacturers understand the additional requirements of the standard, so you know what you need to do for your business and products to meet the regulation. 

Our expert trainers will take you through the MDR, not just from an industry perspective, but also from a Notified Body perspective, which means you get the benefit of understanding what both sides are looking for.

Unlike many other online trainings, we encourage  you to bring and ask as many questions as you like! This is the best way to embed your knowledge and get a thorough understanding of the new regulation. We are here to help you make your medical devices compliant.

This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials.

Course Agenda

▪    Introduction to the EU MDR 

▪    Medical Devices covered by the EU MDR

▪    Placing a device on the market

▪    Device Classification

▪    Unique Device Identifiers (UDI)

▪    Routes to Conformity

▪    Clinical Data Evaluation

▪    Technical File documentation

▪    GSPR & Risk Management

▪    Post Market Surveillance & Vigilance

You have the opportunity to ask as many questions as you like to our expert trainers throughout the course.

Day 1: 8:30am - 16:30pm

Day 2: 9:00am - 16:30pm

Due to the nature of the course, an exact time of each topic can not be provided. 

The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.

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Who should attend?

This MDR training course has great value for anyone involved in implementing or maintaining a QMS.

▪    Quality Assurance professionals

▪    Quality Engineers

▪    Research and Design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

What will I receive? 

▪    PDF training course notes, slides and handouts 

▪    PDF MDR training course certificate 

▪    PDF Indexed copy of the EU MDR 

▪    15% discount on the MDR Guidebook

▪    The opportunity to get your questions answered! 

▪    Full tutor support 

Don't just take our word for it - take a look at just a few of our virtual classroom attendee reviews! 

Eleanor Shackleton

"Thank you for providing me with a high level overview of the Medical Device Regulation 2017/745, the course has helped me to understand what I need to do in order to transition the business from the Medical Device Directives (93/42/ECC), I would highly recommend this course." 

Carolyn Boughton

"Thanks a million, the course was excellent and very enjoyable!"

David Jacobs

"I really enjoyed this course and took a lot away from it, Rod is an excellent tutor. I now know what I need to do for our MDR transition! I have recommended this course to my colleagues, thanks again" 

Address

Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk

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