The medical sector is constantly changing, whether in terms of patients’ needs or requirements regarding quality, safety or innovation. Actors in the health care industry must remain competitive at all times, and integrate scientific, economical as well as sanitation constraints while meeting national and international regulatory requirements to guarantee safety of practitioners, users and patients.
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LNE works in particular in collaboration with the ANSM (French National Agency for Medicines and Health Products Safety) and the HAS (French National Authority for Health), but also with industrial partners to:
As a member of TEAM-NB, the association of notified bodies, LNE has been one of the initiators of the “Code of Conduct for Notified Bodies” since 2011. The Code aims at setting up a series of requirements that would enable to establish a coherent quality level between notified bodies to increase confidence in CE marking of medical devices.