additional Ressources

Guides du MDCG, a range of guidance documents to assist stakeholders in implementing the medical devices regulations.
Articles of BSI, guidances on key standards, regulatory and technological developments in the medical devices sector.
QualitISO, articles, podcasts, tools.
MD101 Consulting, expert network, trainings, webinars and MedTech events.

Forum and Groups 

Medical Device Coordination Group (MDCG).
International Medical Device Regulators Forum (IMDRF), replace Global Harmonization Task Force (GHTF). IMDRF is an organization comprised of medical device regulators from Australia, Brazil, Canada, China, the EU, Japan and the USA with the desire to accelerate global medical device regulatory harmonization and convergence.


Eudamed2, European Databank on Medical Devices

MAUDE, Manufacturer and User Facility Device Experience, FDA database for medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions.