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French accreditation committee COFRAC – Accreditation no. 4-0038. Scope available on www.cofrac.fr
Our goal is to provide Medical Device and In Vitro Diagnostics manufacturers worldwide with the best in Product Certification and Quality Management System (QMS) services.
Rules for G-MED Certification of Quality Management Systems
The object of the present Rules is to specify the terms and conditions for the certification of Quality Systems by LNE (Laboratoire National de métrologie et d’Essais), a notified body, in accordance with the national and international regulations applicable to quality assurance for the design, production, distribution or provision of a service in the field of health and medical devices.
Rules for LNE certification of Management Systems
The present rules aim at introducing and defining the certification procedure for management systems for the purpose of LNE issuing a certificate attesting that a management system complies with the system-related standard which is defined by contract.The rules specify the different stages of certification as well as the related actions and participating parties. They lay down the commitments of the entity applying for LNE certification or the entity holding the certificate issued by LNE as well as LNE’s obligations relating to its certification activity.
ISO Accredited for various healthcare standards:
- ISO 9001 / ISO 13485 Quality Management System
- ISO 14001 Environmental Quality System
- ISO 15378 Packaging Materials for Medicinal Products
Mutual Recognition Agreements / Partnerships: Australia, New Zealand, Taiwan, Japan, Brazil
Accredited Certification Organization by France's accreditation body COFRAC
- Registrar recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS)
- LNE/G-MED applied to be part of the MDSAP program, and is currently an Authorized Auditing Organization
LNE is a Notified, Designated, or Competent Body for the Following Directives: