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North America’s Training Center
Technical Documentation per (EU) Medical Devices Regulation 2017/745
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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 identify and understand the key elements required to establish their technical documentation as part of their CE marking application process.
REQUIRED LEVEL
Good knowledge and effective practice of the European Medical Devices Regulation (EU) 2017/745.
⇒ VIRTUAL TRAINING BUNDLE:
Save up to $350 by combining this training with “European Medical Devices Regulation (EU) 2017/745” training (This offer is only available for the September & November sessions).
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Florianne Torset-Bonfillou Senior International 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
- Identify the component parts of technical documentation for establishing the conformity of medical devices (MD) in line with the requirements of the (EU) Regulation
- Identify the best practices for structuring the technical documentation in line with the expectations of certified bodies and competent authorities in charge of medical devices and market surveillance
Educational Resources
- Presentations
- Practical working sessions
- Course evaluation
Check out the Program
Day 1 & 2
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Program
- Overview of regulations, guides and recommendations
- Identification of applicable requirements
- Content of the technical documentation (TD): structured approach
- Requirements for updating the technical documentation
- Management of the technical documentation: responsibilities and updating procedures
- EC Declaration of conformity: output data of the technical documentation
- Practical working sessions
- Group workshop
- Course Evaluation
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Related Training
European Medical Devices Regulation (EU) 2017/745
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