International regulations for digital medical devices

  • 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.

Read more

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.
Read more

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.
Read more

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.
Read more

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.

Read more

Select a program

M1 Drug Science and Health Products (P7)

  • Core UEs

    15 credits
    • English

      3 credits
    • Quality and technical/regulatory aspects: Technico réglem

      3.5 credits
      • Quality section

      • Technical and regulatory aspects

    • R&D and Drug Registration

      5.5 credits
    • Statistics and scientific watch

      3 credits
  • Registration and Health Product Economics

    5 credits
  • Analytical techniques for drug quality control

    5 credits
  • Toxicological investigation

    5 credits
  • Fundamentals of health product engineering

    5 credits
  • Choice 2

    • Your choice: 1 of 4

      • Pharmacokinetics, pharmacodynamics and biopharmacy

        5 credits
      • Advanced analysis techniques for Medi development.

        5 credits
      • Drug design: Introduction to drug design

        5 credits
      • Corporate knowledge and patent valuation

        5 credits
  • Internship

    10 credits
  • TER 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.

Read more

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
Read more