MGA Elearning 7 : How to leverage regulations to ensure product safety, performance and quality
Useful informations
This elearning training is in French 🇫🇷
Description
Are you a researcher, scientist, engineer?
Are you looking to learn more about health entrepreneurship ? Do you have an idea for a project ?
This e-learning module shows how to leverage regulations to guarantee the safety, performance and quality of your medical device
This elearning is part of a series dedicated to entrepreneurship: discover at your own pace how to articulate science and business, as well as the essential skills to develop an innovative project.
These modules are part of the Medtech Generator & Accelerator program supported by Bpifrance: www.mga-program.com
What you will learn
- Recognize whether your product is a medical device, and is subject to medical device regulations
- Anticipate the process for obtaining CE marking, essential for bringing your product to market
- Prepare evidence : technical file, quality management system, risk management plan
- Prepare the successful completion of a clinical trial
- Use regulations to support the company’s development strategy and establish internal processes
Content of the training
Sequence 1:
Discover the experience of entrepreneurs with regulations : testimony of Samir Medjebar, General Manager at BioSerenity, and Malo Louvigné, Chief Technical Officer at Healthy Mind
Sequence 2:
Why should you focus on regulations when developing your healthcare startup? by Sébastien Giraudier, director at Neighborhood, the innovation center of Voisin Consulting Life Science
Sequence 3:
How to determine whether your product is subject to regulations? by Sébastien Giraudier, director at Neighborhood, the innovation center of Voisin Consulting Life Science
Sequence 4:
How to obtain CE marking for your medical device? by Sébastien Giraudier, director at Neighborhood, the innovation center of Voisin Consulting Life Science
Sequence 5:
Clinical studies: how to get them right? by Sébastien Giraudier, director at Neighborhood, the innovation center of Voisin Consulting Life Science
Sequence 6:
How to incorporate regulations into your corporate strategy? by Sébastien Giraudier, director at Neighborhood, the innovation center of Voisin Consulting Life Science
Sequence 7:
Case study / Practical exercise
Intermediate exercices will guide you throughout the module
Teaching team
For any question :
Contact the Open Brain School team: education@icm-institute.org
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