Masterclass : Clinical research – Regulatory Aspects in the development of a medical device 

This MasterClass will be held in French 🇫🇷

 

Description

During medical device development, the implementation of a clinical trial is often required for the medical device evaluation. The regulatory step and procedures are specific to clinical research including a medical device.   

This training is a global vision of the steps and approaches from the initiation of the medical device development to its CE marking and its market surveillance  

This training is intended for researchers and/or start-up actors (biotech, medtech or digital) who could conduct clinical trials for their research or during the development of a medical device. 

Prerequisites: no

 

What you will learn

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Participants will be able to position themselves in :

• the classification of medical devices   
• the regulatory requirements (Regulation (EU) 2017/745 on medical devices) 
• the role and responsibilities of the sponsor in the development of a medical device 
• the vigilance in clinical research involving a medical device 
• Co-build a target people organization & the staffing plan to accelerate growth

 

Content of the training

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• Definition of a medical device 
• Classification according to Eupropean Regulation 
• CE Marking 
• Steps in the development of a medical device 
• Clinical evaluation 
• Clinical investigation on a medical device in France 
• Vigilance and market surveillance 

 

Teaching team

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Ressources