Useful links

Here is a non-exhaustive list of the resources that we use when we work on medical devices, on R&D, Quality, or Regulatory aspects. Come and consult this page regularly, we will try to keep it up to date in order to provide you with the best resources.


Regulatory Resources


Additional Resources

  • MDCG Guides, aimed at ensuring the uniform application of the new regulation by the various players in the Medical Devices industry.
  • QualitISO, Guillaume Promé's website containing interesting monitoring and numerous articles and resources.
  • CSDmed, website of the CSDmed company containing articles on various subjects surrounding medical devices. 😉 Do not hesitate to contact us to discuss your issues or to request the writing of articles of interest to you.


Organizations

  • EMA reference website at European level. The European Medicines Agency (EMA) helps protect and promote human and animal health by evaluating and monitoring medicines within the European Union (EU) and the European Economic Area (EEA).
  • Medical Devices Coordination Group (GCDM, MDCG in English). The Medical Devices Coordination Group (MDCG) addresses key issues in the medical devices sector, from notified body (NB) surveillance or standardization to market surveillance, international issues, new technologies and clinical investigation.
  • International Medical Device Regulators Forum (IMDRF), formerly Global Harmonization Task Force (GHTF). The IMDRF is an organization bringing together the regulatory authorities of Australia, Brazil, Canada, China, the EU, Japan, Russia, South Korea, Singapore, and the USA. The objective is to strategically accelerate international convergence of medical device regulation, to promote an effective and efficient regulatory model for medical devices that addresses emerging challenges while protecting and maximizing patient health and safety .
  • ANSM National Agency for Health and Medicines, which is the competent authority in France. The ANSM is the public actor which allows, on behalf of the State, access to health products in France and which ensures their safety throughout their life cycle. Each EU country has its own competent authority, you will find the list of competent authorities by country by following this link.
  • ISO, International Standard Organization. ISO (International Organization for Standardization) is an independent, non-governmental international organization whose 169 members are national standards bodies. Through its members, the Organization brings together experts who pool their knowledge to develop voluntary International Standards, based on consensus, relevant to the market, supporting innovation and providing solutions to global challenges.
  • Department of Health Affairs in Monaco, in charge of all missions relating to health action.


Data base

  • EU legislation - EUR-Lex, Official Journal of the European Union authoritative of EU legislation, EU case law, consolidated texts, summaries of legislation, etc.
  • Eudamed, European Databank on Medical Devices. EUDAMED is a new European database on medical devices. It will allow the public to have access to information on medical devices marketed in Europe, to know about incidents, etc
  • MAUD, Manufacturer and User Facility Device Experience, FDA database of reported events related to medical devices.