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Latest update : 28.11.2018
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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. 4-0608
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, GMED 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:

GMED 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):

GMED 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

GMED 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)

GMED 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), GMED 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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