Because we strive for excellence, we continuously build and maintain a core of experts in knowledge and technology to share and support the needs and expectations of our customers.
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.
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: