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

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

Course Objectives

   

TUV USA is proud to host our Second Annual Medical Device Roadshow. We are offering 3 classes in a 5 day consecutive training consisting of:

  • MDD to MDR Transition
  • MERCOSUR
  • MDSAP Internal Auditor

INTERESTED?

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.
Day 1

  • Understand the Medical Device Regulations approach in Europe
  • Understand the Responsibilities and definitions under the MDR
  • Understand the use of Safety and Performance requirements, including the use of hramonized standards
  • Identify the applicable Conformity Assessment Procedure
  • Understand how to prepare for the move from MDD to MDR 

Day 2

  • Understand the development from MDD to MDR
  • Understand the Requirements of the new post marketing part of the technical documentation
  • Understand to align the MDR requirements with international requirements
  • Be prepared for the new CE-Marking

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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