European Medical Devices Regulation (EU) 2017/745
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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-Bonfillou Regulatory Affairs and Education Leader, GMED North America
Ibim Tariah Senior Advisor Regulatory Strategy and Product Reviewer, GMED North America
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
- 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
Related
Trainings
The Clinical Evaluation Report (CER) requirements under the EU MDR 2017/745
Attendees Testimonials
Lisa Maloney Director of Regulatory Affairs and Quality Assurance
Martha Rumford Director, QA/RA
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