Medical Device Regulation (EU MDR) 2017/745
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.
Our virtual courses bring you, our expert tutors and fellow delegates together on a web based classroom where you can fully engage in group activities, ask questions and share materials as if you were in a real classroom.
This course can be accessed through Google Chrome or if you are able to, you can download the training course software after booking.
▪ 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 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 Indexed copy of the EU MDR
▪ 15% discount on the MDR Guidebook
▪ Full tutor support and access during course times
Our software will allow you to:
▪ Raise your 'virtual' hand to ask questions
▪ Participate in polls and surveys and see results
▪ Undertake exercises on your own or in a group
▪ Download and share materials and documents
▪ Chat online with the facilitators and other delegates