Medical Device Regulation (EU MDR) 2017/745
If you already 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, this 2 day MDR training course is most definitely for you.
This course has been created by our industry leading experts 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 new MDR.
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.
▪ Introduction to the EU MDR
▪ Medical devices covered by the regulation
▪ Classification of your devices
▪ How to achieve conformity
▪ What your importers, distributors and authorised reps need to do
▪ Clinical Data Evaluation
▪ Technical File documentation
▪ What labelling 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
Day 1: 8:30am - 16:30pm
Day 2: 9:00am - 16:30pm
The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.
This is a classroom based course filled with practical and interactive activities to embed your learning.
Who should attend?
This EU 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?
▪ Training course notes
▪ Indexed copy of the EU MDR
▪ Paperback copy of the MDR Guidebook (RRP £225)
Our team Is on hand to support you with any B&B bookings if required.
Any of our courses can be delivered on-site at your premises.
Contact us today to find out more.