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Accreditation

Over 35 COFRAC accreditations

LNE is one of most respected and reputable certification bodies in the world.

> COFRAC

LNE is ISO 17021-1:2015 accredited by COFRAC (Accreditation N°4-0038) for its activities of Quality Management System Certification according to ISO 9001:2008, ISO9001:2015 and ISO 13485:2003; ISO 13485:2016 and NF EN ISO 13485:2016 standards in medical devices and health field.

LNE is also accredited for other non-medical Quality Management System ISO standards:

Details on LNE’s accreditation with COFRAC can be found on this page

 

> European Notified Body (CE 0459)

LNE is notified to the following Medical Device Directives

In addition to the above mentioned notifications, LNE is also a Notified, Designated, or Competent Body for the following Directives:

 

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 CMDCAS Registar

LNE is a Registrar recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS)

 

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 MDSAP Authorized Organization

LNE/G-MED is currently an Authorized Auditing Organization for the Medical Device Single Audit Program (MDSAP).

> Mutual Recognition Agreements / Partnerships

LNE/G-MED is recognized as a conformity assessment body (CAB) under mutual recognition agreements signed by the European Union with Australia and New Zealand.

> Taiwan

LNE/G-MED is accredited since November 2004 by the Ministry of Health of Taiwan to carry out audits according to ISO 13485.

> CB Scheme

Under the international agreements of CB Scheme, LNE is recognized by IECEE as a National Certification Body and a Testing Laboratory (Certification Body and Testing Laboratory, CBTL).

 

Rules of Certifications

> Rules for G-MED Certification of Quality Management Systems

The object of the present Rules is to specify the terms and conditions for the certification of Quality Systems by LNE (Laboratoire National de métrologie et d’Essais), a notified body, in accordance with the national and international regulations applicable to quality assurance for the design, production, distribution or provision of a service in the field of health and medical devices.

> Rules for LNE Certification of Management Systems

The present rules aim at introducing and defining the certification procedure for management systems for the purpose of LNE issuing a certificate attesting that a management system complies with the system-related standard which is defined by contract. The rules specify the different stages of certification as well as the related actions and participating parties. They lay down the commitments of the entity applying for LNE certification or the entity holding the certificate issued by LNE as well as LNE’s obligations relating to its certification activity.

Combo Training ISO13485 MDSAP

Questions?

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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

Click here to Register