Medical Device Regulation (MDR) Implementation
Medical Device Regulation (EU) 2017/745 training course
Category: MDR training, EU MDR training course
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, then this MDR training course is most definitely for you.
Our two day 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 new MDR 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.
▪ 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
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