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

Useful informations

This MasterClass will be held in French 🇫🇷



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

For further information:


What you will learn

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

  • 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



Has been working in clinical research for more than 15 years (in pharmaceutical industry, within CROs and since 2017 within the Paris Brain Institute).

  • Jennifer IDUSOGIE,

Pharmacist, has been working in clinical research for more than 5 years (in pharmaceutical industry and since 2021 within the Paris Brain Institute). 

  • Magali REGNIER,

PhD, has been working in clinical research for more than 13 years (in hospital groups, industries and since 2021 at the Paris Brain Institute)



  • Training support and documentation in pdf format 
  • Useful links to improve your knowledge