Duration
2-Day
Day 1 9:00 AM to 5:30 PM
Day 2 9:00 AM to 5:30 PM
Cost
$1,695.00 USD for US and International Attendees
$1,695.00 CAD plus applicable taxes for Canadian Attendees
Discounts Offered
10% Early Bird discount when registered 90 days prior to the class
10% Group Rate 3+
15% Combination Early Bird/Group Rate 3+
Certificates
Participants will receive the below certificates at the conclusion of the course. All certificates are issued by TUV USA.
Certificate of Attendance to the attendant who participates in the entire course.
Certificate of Successful Completion to the attendee who passes the examination.
Course Objectives
The aim of this 2 day course is to provide information and knowledge about the Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition and Technical Documentation Training on MDR.
Learning Outcomes: What can the participants expect to learn in the course?
- Understanding transition regulations for Medical Devices Directive (MDD) to Medical Devices Regulation (MDR)
- Knowing how to prepare Technical Documentation for MDR
- Getting familiar with common probable failures in technical documentation
Course Agenda
Day 1 - MDD to MDR Transition
Introduction and welcome
Introduction of objective/goals of the training.
1. Background information European legislation
2. Scope & Definitions of the MDR
3. Economic operators and Manufacturer’s responsibilities
4. General Safety and Performance Requirements
5. Notified Bodies
6. Classification and Conformity Assessment
7. Presumption of Conformity, Standards and Common Specifications
8. The Quality requirements under the MDR
9. Risk Management under the MDR
10. PMS & Vigilance
11. EUDAMED & UDI
Day 2 - Technical Documentation for MDR
Introduction and welcome
Introduction of objective/goals of the training.
1. Basics of the Technical Documentation under the MDR
2. Technical documentation in relation to the Conformity assessment Procedure
3. Elements of the „Pre-Marketing“ Technical Documentation
4. Elements of the new „Post-Marketing“ Technical Documentation
5. In Depth review of certain elements of the Technical Documentation
6. How to prepare for world wide harmonization