Technical Documentation per Medical Devices Regulation (EU) 2017/745
Identify and understand the key elements required in the medical device technical file
1.5-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 companies identify and understand the key elements required to establish their medical technical file 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.
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Amy Chan Product Reviewer, GMED North America
Amy is a seasoned medical device professional with 15 years of extensive experience in the pharmaceutical and medical device fields. Throughout her career, she has worked as an engineer in research and development, manufacturing, and quality assurance at renowned medical device companies such as Medtronic, Abbott Vascular, Allergan and AbbVie. In these roles, she has served as a pivotal part in facilitating the market entry of innovative and life-saving medical devices. For the past 5 years, Amy has worked as a product reviewer at notified bodies specializing in the review of non-active cardiovascular devices.
Amy is currently a product reviewer in Cardiology at GMED North America. Amy holds a Master’s degree in Bioengineering from University of California, San Diego.
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
- 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
- Summary and Discussion with the trainer
- Group workshop
Related Training
European Medical Devices Regulation (EU) 2017/745
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