If you sell medical devices into Europe, you probably already know that CE marking is changing. But do you fully understand what the impact is for your business, products and your supply chain? 

 

If you are not 100% sure or would like to refresh your knowledge, then this course is most definitely for you. Our expert trainers can take you through the regulation, 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.  

 

All of our courses are structured to optimise your learning using accelerated learning techniques and exercises to consolidate understanding. You will be actively engaged with emphasis on questions and group discussions to further assist understanding.   

 

Not only do we offer a 2-day detailed introduction, we offer a comprehensive 5-day course. The 2-day course isn't just a simple 'read and understand,' it is a practical 'how to' guide, which you can actually use immediately.

 

Plus, you also get your own copy of the Meddev Solutions MDR guidebook! (Also available separately). The guidebook provides a series of tools to help you apply the requirements of the MDR into your company.

MDR Training

Who should attend?

The content will have great value to individuals who are involved in any aspect of implementing or maintaining a QMS.  

▪    Quality assurance professionals

▪    Quality Engineers

▪    Research and design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

2-day course overview:

 
▪    The story so far – where we are at and why we have had to make changes
▪    Medical devices covered by the regulation (these have changed!)
▪    Classification of your devices
▪    How to achieve conformity through selection of appropriate Annexes
▪    What your importers, distributors and authorized representatives need to do
▪    Clinical Data Evaluation
▪    Technical File documentation
▪    What labeling is required on your devices (including UDI)
▪    Risk Management Files and how the process works 
▪    Vigilance activities
▪    Post Market Surveillance
▪    What reporting is required under the new regulation

£895 Including Guidebook

2-day MDR Training Course Inc. Guidebook

Date: December 10th 2019 at 8:30am

Venue: 3form Design, The Chapel, Whitchurch, RG28 7LN

Screenshot 2019-05-07 at 11.49.09.png

Upcoming public course dates:

2-day MDR Training Course Inc. Guidebook

Date: January 20th 2020 at 8:30am

Venue: 3form Design, The Chapel, Whitchurch, RG28 7LN

Screenshot 2019-05-07 at 11.49.09.png

Upcoming public course dates:

Screenshot 2019-08-29 at 11.35.52.png
Download the 2-day MDR Flyer

© 2019 Meddev Solutions Ltd

Company Registration NI645349

Newry

BT34 2DL

United Kingdom

VAT no. 267 7231 82

  • Facebook - Black Circle
  • LinkedIn - Black Circle