ECTS
120 credits
Duration
2 years
Training structure
School of Pharmacy
Presentation
The International Regulation of Digital Medical Devices (RIDMN) course focuses on studying 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 meeting the growing needs for innovation and regulation in a rapidly expanding sector.
The advantages of the training program
This course is part of the Digital Health School at the University of Montpellier (ESNbyUM), supported by the France 2030 Investment for the Future Program. ESNbyUM aims to:
- Training experts capable of meeting the challenges of digital health.
- Contributing 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:
- Understanding and applying international regulations.
- Develop and register digital medical devices.
- Manage risks and ensure regulatory compliance.
- Collaborate with regulatory bodies and companies.
Know-how and skills
- Expertise in international regulations (EU, USA, Asia).
- Mastery of digital medical device registration processes.
- Quality and risk management according to ISO standards.
- Knowledge of digital technologies applied to healthcare.
- Skills in innovation and entrepreneurship.
Program
Close ties with the professional world through collaborations with companies and regulatory bodies enable students to participate in real-world projects, complete internships or work-study programs, and work on case studies. Supervised by experts from academia and industry, they receive both theoretical and applied training. A core curriculum shared with other programs provides them with essential cross-disciplinary knowledge.
Select a program
M1 Medicinal Sciences and Health Products (P7)
Core Curriculum Units
15 creditsRegistration and Economy of Health Products
5 creditsAnalysis Techniques for Drug Quality Control
5 credits
Fundamentals of Health Product Engineering
5 creditsChoice 2
Choose 1 out of 4
Internship
10 creditsTER course Regulatory environment
5 credits
M2 International Regulation of Digital Medical Devices
Admission
Admission requirements
For M 1: hold a bachelor's degree in science providing a solid foundation in biological or chemical sciences (including physical chemistry), VAE.
For the M2: hold a Master 1 degree in Medicines and Health Products Science, biology, biochemistry, molecular and cellular biology, a degree in pharmacy, medicine, veterinary medicine, be a student in DFASP2 or DFASM3, an intern in Pharmacy or Medicine, a computer engineer, a graduate with a master's degree in computer science, or have VAE (validation of acquired experience).
And after
Professional integration
- Regulatory Affairs Manager
- Digital Medical Devices Project Manager
- Regulatory and Digital Innovation Consultant
- Quality and compliance manager in digital health companies