ECTS
120 credits
Duration
2 years
Training structure
Faculty of Pharmacy
Presentation
The International Regulation of Digital Medical Devices (RIDMN) program focuses on the regulatory framework for digital medical devices throughout their life cycle. Combining theory, practice and interaction with industry experts, this program trains specialists capable of responding to the growing need for innovation and regulation in a rapidly expanding sector.
Training benefits
This course is part of the Montpellier University School of Digital Health (ESNbyUM), supported by the France 2030 Future Investment Program. ESNbyUM aims to :
- Train experts capable of meeting the challenges of digital health.
- Contribute to innovation in digital medical devices.
- Promoting an ethical and sustainable approach to the digital transformation of healthcare.
- Train specialists to meet international regulatory requirements.
Objectives
Train experts capable of :
- Understand and apply international regulations.
- Develop and register digital medical devices.
- Manage risk and ensure regulatory compliance.
- Collaborate with regulatory authorities and companies.
Know-how and skills
- International regulatory expertise (EU, USA, Asia).
- Control of digital medical device registration processes.
- Quality and risk management according to ISO standards.
- Knowledge of digital technologies applied to healthcare.
- Innovation and entrepreneurship skills.
Program
Our close links with the professional world, through collaborations with companies and regulatory bodies, enable students to take part in practical projects, complete internships or work-study periods, and work on case studies. Supervised by experts from academia and industry, they benefit from both theoretical and applied training. A core curriculum shared with other courses provides essential cross-disciplinary knowledge.
Select a program
M1 Drug Science and Health Products (P7)
Core UEs
15 creditsRegistration and Health Product Economics
5 creditsAnalytical techniques for drug quality control
5 creditsToxicological investigation
5 credits
Fundamentals of health product engineering
5 creditsChoice 2
Your choice: 1 of 4
Internship
10 creditsTER Regulatory Environment track
5 credits
M2 International Regulation of Digital Medical Devices
Admission
Admission requirements
For M 1: Hold a scientific L3 degree with a solid grounding in biological or chemical sciences (including physical chemistry), VAE.
For M2: holders of a Master 1 in Drug and Health Product Sciences, biology, biochemistry, molecular and cellular biology, a pharmacist's, doctor's or veterinarian's diploma, DFASP2 or DFASM3 students, pharmacy or medicine interns, IT engineers, IT master's graduates, VAE.
And then
Professional integration
- Regulatory Affairs Manager
- Digital medical devices project manager
- Regulatory and digital innovation consultant
- Quality and compliance manager for digital healthcare companies