1 rue Gaston Boissier
75724 Paris Cedex 15
France
Phone: +33 1 40433700
Fax: +33 1 40433737
http://www.lne.fr
info@lne.fr
Company Figures
Number of employees 500-999
Year of foundation 1901
Area of business Services and Publications
Company Profile
Your needs: our priority
LNE is attentive to the needs of its customers. It takes into account the exact requirements of each company in offering the most comprehensive range of services for medical sector:
– Certification on health and medical devices sector by LNE/G-MED (accredited by Cofrac): French notified body for all categories of medical devices and all conformity assessment procedures. It is also recognized by the Canadian, American, Tawainese and Japan ministries for specific programs as a third-party assessment body, Brazil for the electro medical devices and under the CB Scheme.
– Measurements and tests of medical devices, quality product certification (NF Médical), inter and intra training sessions by LNE. Tests on all types of medical devices among which orthopedics, biomaterials, electro medical insturments, hospital equipment, consumables and active implantable medical devices.
Successful certification and access to new markets with LNE/G-MED:
– Access to CE marking (CE 0459): all categories of medical devices and all conformity assessment procedures;
– Access to others markets: Canada, United States, Taiwan, Australia, New Zealand, Japan, Brazil (for electro medical devices); LNE tests and certificates are also recognized under the CB Scheme for electro medical devices in 50 countries;
– Mandatory and voluntary certifications: ISO 13485, sterilisation process (EN 550 – EN 552 – EN 554), NF Medical mark, QSE: ISO 9001 – ISO 14001 – OHSAS 18001.
LNE additional services in the medical sector
– Testing: mechanical tests, metallurgical analysis, chemical analysis, ageing, dimensional control, electrical and EMC tests;
– Metrology;
– Training.
A new service: Pre-assessment audits (including for QSE certification) for all above standards to optimize your certification effort.