LNE/G-MED recognition and accreditation
Certification of quality management systems:
LNE/G-MED is accredited according to standard EN 45012 for certification of quality management systems to standards ISO 9001 and ISO 13485 in the medical device field by the following bodies:
French accreditation committee COFRAC – Accreditation no. 4-0038
>> For more information and scope of accreditation, see the COFRAC website
Standards Council of Canada (SCC)
- Accreditation no. 1009-8/30
Under the CMDCAS programme, LNE/G-MED is recognized as a registrar by Health Canada.
>>For more information, see our page Access to the Canadian market and the Health Canada website.
Product certification:
LNE is accredited according to standard EN 45011 for certification of products (NF mark) by:
French accreditation committee COFRAC - Accreditation no.
5-0012
>> For more information and scope of accreditation, see the COFRAC website
CE marking:
LNE/G-MED is accredited by French Health Products Safety Agency AFSSAPS as a notified body (no. 0459) for all assessment operations covered by the European Directives on medical devices.
>>For more information, see our page CE marking
and LNE notification on Nando website
Mutual recognition agreements (ARM):
LNE/G-MED is recognized as a conformity assessment body (CAB) under mutual recognition agreements signed by the European Union with the United States, Australia and New Zealand.
>>For more information, see our pages Access to the American market and Access to the Australia and New Zealand markets
Taiwan
LNE/G-MED is accredited by Taiwan’s Ministry of Health to perform audits according to standard ISO 13485.
>>For more information, see our page
Access to the Taiwanese market
Food and Drug Administration (FDA)
LNE/G-MED is accredited by the American Food and Drug Administration (FDA) as a third party body or AP (Accredited Person) to perform inspections authorized by the FDA.
>>For more information, see our page Access to the American market