envelopecontact us

phone1-301-495-0477

Over 35 COFRAC accreditations

ce notified body europe 0459LNE is one of most respected and reputable certification bodies in the world.

Because we strive for excellence, we continuously build and maintain a core of experts in knowledge and technology to share and support the needs and expectations of our customers.

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

Our goal is to provide Medical Device and In Vitro Diagnostics manufacturers worldwide with the best in Product Certification and Quality Management System (QMS) services.

>  European Notified Body (CE 0459)

ISO Accredited for various healthcare standards:

  •  ISO 9001 / ISO 13485 Quality Management System
  •  ISO 14001 Environmental Quality System
  •  ISO 15378 Packaging Materials for Medicinal Products

Mutual Recognition Agreements / Partnerships: Australia, New Zealand, Taiwan, Japan, Brazil

Accredited Certification Organization by France's accreditation body COFRAC

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

  •  LNE/G-MED applied to be part of the MDSAP program, and is currently an Authorized Auditing Organization

 

LNE is a Notified, Designated, or Competent Body for the Following Directives:

 

combo ISO 13485 9001

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

lne gmed arrow Submit a request

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.

Don't have an account yet? Register Now!

Sign in to your account