European Medical Devices Regulation (EU) 2017/745
Understand and assess the changes introduced by the Regulation
2-day training session | Virtual Classroom
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.
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Florianne Torset-Bonfillou Senior International Regulatory Project Manager; Lead Auditor & Product Reviewer, GMED North America
Florianne is a Senior International 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
- 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
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