Obelis s.a. (O.E.A.R.C.) is now offering an invaluable and
essential service to medical device manufacturers regarding the
GMDN (Global Medical Device Nomenclature). O.E.A.R.C. will assist
manufacturers in obtaining their code identification and will
provide assistance for new code submission services.
The Global Medical Device Nomenclature (GMDN) is a comprehensive
system of internationally recognized coded descriptors in the
format of preferred terms with definitions used to generically
identify medical devices and related health care products. It is
used not only in Europe, but also for the most part worldwide as a
means for identifying all medical devices.
The GMDN was founded by Medical Device experts from around the
world (manufacturers, healthcare authorities and regulators) who
compiled the initial GMDN nomenclature based on the standard ISO
15225. The work was mandated by the European Commission in order
to provide the necessary tool to carry out many of the obligations
following the implementation of the Medical Devices Directives.
Also, to meet similar needs at the Global level as identified in
the Global harmonization activities of GHTF by its members, notably
USA (FDA), Canada, European member states, Japan, Australia and now
by many other countries/regions (http://www.gmdnagency.com/
Obelis, with over 19 years of experience and expertise,
hopes to be able to assist manufacturers with these issues
regarding the GMDN. It will continue to add value to its core
services by offering key services such as those mentioned above.
It will also be developing new services and expanding its current
services to meet the demands of manufacturers for the ever growing
global regulations. (www.obelis.net).