ECTS
120 credits
Duration
2 years
Training Structure
School of Pharmacy
Overview
The International Regulation of Digital Medical Devices (RIDMN) track is a program focused on the regulatory framework governing digital medical devices throughout their “lifecycle.” 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 Benefits of the Training Program
This program is part of the University of Montpellier’s School of Digital Health (ESNbyUM), supported by the France 2030 Investment for the Future Program. The ESNbyUM aims to:
- To train experts capable of addressing the challenges of digital health.
- Contribute to innovation in digital medical devices.
- Promote an ethical and sustainable approach to the digital transformation of healthcare.
- Train specialists to meet international regulatory requirements.
Objectives
To train experts who are able to:
- Understand and apply international regulations.
- Develop and register digital medical devices.
- Manage risks and ensure regulatory compliance.
- Work with regulatory agencies and companies.
Expertise and Skills
- Expertise in international regulations (EU, U.S., Asia).
- Expertise in the registration processes for digital medical devices.
- Quality and Risk Management in Accordance with ISO Standards.
- Knowledge of digital technologies applied to healthcare.
- Skills in innovation and entrepreneurship.
Program
Close ties to the professional world, fostered through collaborations with companies and regulatory agencies, allow students to participate in real-world projects, complete internships or work-study programs, and work on case studies. Under the guidance of experts from both academia and industry, they receive training that is both theoretical and applied. A core curriculum shared with other programs provides them with essential interdisciplinary knowledge.
Select a program
M1 Pharmaceutical Sciences and Health Products (P7)
UEs Core Curriculum
15 creditsRegistration and Economics of Health Products
5 creditsAnalytical Techniques for Drug Quality Control
5 credits
Fundamentals of Healthcare Product Engineering
5 creditsOption 2
Internship
10 creditsTER Course: Regulatory Environment
5 credits
M2 International Regulation of Digital Medical Devices
Admission
Admission Requirements
For the M 1 program: Hold a bachelor’s degree (L3) in a science field providing a solid foundation in biological or chemical sciences (including physical chemistry), or have equivalent academic credentials.
For the M2: Hold a Master’s 1 degree in Pharmaceutical Sciences and Health Products, biology, biochemistry, molecular and cellular biology; a degree in pharmacy, medicine, or veterinary medicine; be a student in the DFASP2 or DFASM3 program; be a resident in pharmacy or medicine; be a computer engineering graduate; hold a master’s degree in computer science; or have a degree recognized through the validation of prior learning (VAE).
And then
Employment Placement
- Regulatory Affairs Manager
- Project Manager for Digital Medical Devices
- Consultant in Regulatory Affairs and Digital Innovation
- Quality and Compliance Manager at Digital Health Companies