GMED North America’s Training Center

European Medical Device Regulation (EU) 2017/745

Understand and assess the changes introduced by the Regulation

Save on tickets with Early Bird Special, Client and Bundle Discounts**

2 days of training | Virtual Training | $1900 pp

January 28-30, 2025 (3 half-day sessions)
July 15-16, 2025
September 16-17, 2025

About the training

The European Union Medical Device Regulation – Regulation (EU) 2017/745 (or EU MDR) – 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 medical device industry companies get ready for their application to obtain and/or maintain CE marking for their product(s) and:

Gain an understanding of the changes introduced by EU MDR requirements;
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.

SEPTEMBER 16-OCTOBER 16, 2025

Florianne Torset-Bonfillou Senior International Regulatory Project Manager; Lead Auditor & Product Reviewer, GMED North America

Florianne is a Senior International Regulatory Project Manager at GMED North America. She is also a Lead Auditor and a Product Reviewer with focus on high-risk devices, mainly in the cardio and neurovascular field.

She has a background in Biology, Chemistry and Quality Management. After working in the Pharma/Device industry, Florianne first joint GMED as an Assessor, then became part of the Quality & Regulatory support team. For the past 5 years, Florianne provided Regulatory support to the local team for the transition to the European Regulation EU 2017/745 and EU 2017/746. Since 2023, she supports the UK subsidiary towards its UKCA designation.

She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.

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
Group workshop

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
Group workshop
Summary and Discussion with the trainer

Attendees Testimonials

"The trainer was very knowledgeable and she answered most, if not all questions to the satisfaction of the trainees. The training materials / downloads were very useful as well, and I expect I'll refer to them often."

Sr. Premarket RA Specialist

Plan a Training Today

We offer a variety of training courses and we focus on your challenges and provide our attendees with a clear “take-home” value.