GMED
Created in 1994
- BETA
Up & running (A)
Existing signals show a regular activity Social networks
12,550 7,241Activities
Technologies
Entity types
Location
1 Rue Gaston Boissier, 75724 Paris, France
Paris
France
Employees
Scale: 51-200
Estimated: 238
Engaged corporates
8
3 5Added in Motherbase
10 months, 2 weeks ago
healthtech Value proposition
[Automatic translation follows] GMED is a French certification body and notified body in Europe (identification number 0459).
GMED is a French certification body and notified body in Europe (identification number 0459). It is responsible for assessing the conformity of medical devices according to the applicable European directives (90/385/EEC, 93/42/EEC and 98/79/EC).
Accredited by the French Accreditation Committee COFRAC (under certificate No. 4-0608), in accordance with the NF EN ISO/CEI 17021: 2015 standard, GMED carries out quality management system certification activities according to ISO 9001: 2015 and ISO 13485: 2016 standards.
GMED is also an audit body recognized by the MDSAP Regulatory Authority Council as part of its audit program and has been carrying out MDSAP audits since April 2015.
Created in 1994, GMED has been a simplified joint stock company (S.A.S) since August 1, 2018, 100% owned by the LNE, a public industrial and commercial establishment (EPIC) founded in 1901.
GMED's success and high level of performance are based on the excellence and involvement of its teams: Certification Project Managers, Specialists (in Animal-derived Medical Devices (ADMD), Medical Devices incorporating a medicinal substance, Active Implantable Medical Devices (AIMD), etc.), Design File Evaluators / Technical Documentation, Clinical Data Evaluators and Experts in Medical Device Sterilization Methods, Auditors for CE Marking and Quality Management Systems; all have been trained to the highest level of current assessment and audit methods.
With offices in Europe and the creation in 2005 of GMED North America, a subsidiary of GMED in the United States, our organization offers you the efficiency and availability of local teams and experienced specialists to support the certification process, which will allow you to market in your target markets.
medical device certification, ISO 13485:2016, QMS compliance, Notified Body, MDSAP, Regulatory Affairs, Quality, Innovative technologies, in vitro diagnostics, EU MDR 2017/745, EU IVDR 2017/746, and CE MarkingOriginal language
GMED est un organisme de certification et un organisme notifié français en Europe (numéro d’identification 0459).
GMED est un organisme de certification et un organisme notifié français en Europe (numéro d’identification 0459). Il est chargé d’évaluer la conformité des dispositifs médicaux selon les directives européennes applicables (90/385/CEE , 93/42/CEE et 98/79/CE).
Accrédité par le Comité français d'accréditation COFRAC (sous le certificat n ° 4-0608), conformément à la norme NF EN ISO/CEI 17021: 2015, GMED exerce les activités de certification de système de management de la qualité selon les normes ISO 9001: 2015 et ISO 13485: 2016.
GMED est également un organisme d'audit reconnu par le MDSAP Regulatory Authority Council dans le cadre de son programme d’audit et réalise des audits MDSAP depuis Avril 2015.
Crée en 1994, GMED est depuis le 1er Août 2018 une société à actions simplifiée (S.A.S) détenue à 100% par le LNE, un établissement public à caractère industriel et commercial (EPIC) fondé en 1901.
Le succès et le haut niveau de performance de GMED reposent sur l’excellence et l’implication de ses équipes : Chefs de projets Certification, Spécialistes ( en Dispositifs Médicaux d’Origine Animale DMOA, Dispositifs Médicaux incorporant une substance médicinale, Dispositifs Médicaux Implantables Actifs DMIA, etc.), Evaluateurs de dossier de conception / documentation technique, Evaluateurs de données cliniques et Experts dans les méthodes de stérilisation des dispositifs médicaux, Auditeurs pour le marquage CE et les systèmes de gestion de management de la qualité ; tous ont été formés au plus haut niveau des méthodes d’évaluation et d’audit en vigueur.
Avec des bureaux en Europe et la création en 2005 de GMED North America, filiale du GMED aux États-Unis, notre organisation vous offre l'efficacité et la disponibilité d’équipes locales et de spécialistes expérimentés pour accompagner la démarche de certification, , qui vous permettra la commercialisation sur vos marchés-cibles.
medical device certification, ISO 13485:2016, QMS compliance, Notified Body, MDSAP, Regulatory Affairs, Quality, Innovative technologies, in vitro diagnostics, EU MDR 2017/745, EU IVDR 2017/746, and CE Marking
GMED - Dedicated to Health and Innovation in Medical Devices
Learn more on GMED and how they serve the medical device industry worldwide to meet the requirements of European medical device regulations
https://lne-gmed.com/
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