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European Medical Devices Regulation (EU) 2017/745

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Next Training Date Jul 13 - 14, 2023 , Training | Virtual Classroom

About the training

The European Regulations on Medical Devices (including Active Implantable Medical Devices AIMD) – MDR EU 2017/745 – was published on May 5th, 2017 and entered into force on May 25th, 2017. GMED North America has designed a comprehensive training course to help companies get ready for their application to obtain and/or maintain CE marking for their medical device product(s) and:

  • Gain an understanding of the changes introduced by both European Medical Device Regulation – MDR EU 2017/745;
  • Assess the impacts of those changes on their organizational and structural activities.

REQUIRED LEVEL

Good knowledge and effective practice of the Directives 93/42/EEC or/and 90/385/EEC.     

             ⇒ VIRTUAL TRAINING BUNDLE:                                 

Save up to $350 by combining this training with “Technical Documentation per (EU) Medical Devices Regulation 2017/745” training (This offer is only available for the July & August sessions).

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Trainers

Florianne Torset BonfillouFlorianne Torset-Bonfillou  Regulatory Affairs and Education Leader, GMED North America

Sept. 27-28 session

 

 

IbimIbim Tariah                        Senior Advisor Regulatory Strategy and Product Reviewer, GMED North America

July 13-14 session                                                         Dec. 7-8 session

Who Should Attend

  • Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R&D specialists, Development, Manufacturing and Marketing Managers
  • Internal and external Auditors
  • Importers
  • Distributors

Learning Objectives

  • Address the new Quality Management System (QMS) requirements
  • Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s)
  • Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s
  • Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management
  • Implement the requirements for labelling, the Unique Device Identification (UDI) and EUDAMED
  • Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.)

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program

Day 1 & 2
-
Program
  • Regulation structure
  • Scope and Definitions
  • Actors and Responsibilities
  • Device Classification Criteria
  • Conformity Assessment routes
  • Quality Management System requirements
  • Technical Documentation
  • Post Market Surveillance and Vigilance reporting requirements
  • The Transition
  • Practical working sessions
  • Group workshop
  • Course Evaluation
  • Summary and Discussion with the trainer
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We serve your passion for progress in the Medical Device Industry

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Attendees Testimonials

“Great and relevant situational examples of what the trainer has seen based on her experience as it relates to the subject content. Overall, I am very happy I went to the workshop. I feel better equipped to tackle the MDRs.”
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Lisa Maloney Director of Regulatory Affairs and Quality Assurance

“The trainer was very knowledgeable and open to my many questions. Workshop activities were helpful. I feel more confidence in leading our organization toward the new MDR world.”
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Martha Rumford Director, QA/RA

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