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Latest update : 21.12.2016
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Home | LNE/G-MED recognition and accreditation

LNE/G-MED recognition and accreditation

Certification of quality management systems:

LNE/G-MED is accredited according to standard ISO 17021 for certification of quality management systems to standards ISO 9001 and ISO 13485 in the medical device field by the following bodies:

COFRAC logo
French accreditation committee COFRAC – Accreditation no. 4-0038
Scope available on www.cofrac.fr

>> For more information and scope of accreditation, see the COFRAC website


SCC logo
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 ISO 17065 for certification of products (NF mark) by:

COFRAC logo
French accreditation committee COFRAC - Accreditation no. 5-0012
Scope available on www.cofrac.fr

>> For more information and scope of accreditation, see the COFRAC website


CE marking:

LNE/G-MED is accredited by Agence nationale de sécurité du médicament et des produits de santé (ANSM) 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

Japan

Under the recognition agreement signed with JQA (Japan Quality Assurance organization), LNE/G-MED is a JPAL authorized body for the audit of quality management system (QMS).
>> For more information, see our page Access to the Japanese market

CB-Scheme Programme

As part of CB Scheme’s international agreements, LNE is recognized by IECEE as a National Certification Body and Testing Laboratory – CBTL
>> For more information, see our page CB Scheme certification

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