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Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) Transition & Technical Documentation

    1. Academy
    2. Medical Devices
    3. MDD to MDR Transition Class

   

Duration

2-Day 

Day 1 9:00 AM to 5:30 PM

Day 2 9:00 AM to 5:30 PM

Cost

$1,295.00 USD/CAD per participant 

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

 

 

Need more information on this class? Contact us.

Katie Lehoullier


Katie Lehoullier joined the TUV USA team in 2016 as Administrative Office Support. Katie assists in the development of TUV USA’s Academy Division as the Training Coordinator.

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