Status of LNE/G-MED:
notified body
Accreditation number:
0459
|
| Services provided
by LNE: |
LNE will:
provide expert advice concerning classification of devices
and certification procedures,
issue the certificates required for CE marking,
carry out an EC examination of design files,
carry out EC type-examinations,
perform conformity tests to harmonized European standards
or other standards,
perform quality system audits in accordance with the Directive
Annexes,
assess clinical data in consultation with hospital experts
|
| Scope: |
Medical devices and their accessories
|
| How to comply
with the Directive? |
Download the LNE/G-MED
Guidelines (PDF format)
|
| LNE/G-MED strengths: |
LNE/G-MED issues certificates for
all conformity procedures and
all medical devices covered by the Directive.
Technical file examinations and audits are performed by
qualified experts who are specially
trained for each category of devices.
Quality system audits are performed anywhere
in the world.
LNE/G-MED is actively involved in the work of NB-MED (Coordination
of Notified Bodies for Medical Devices) and European standardization
bodies.
|
| Additional services: |
one-stop auditing for ISO 9001, EN/ISO 13485, EN/ISO 13488
and mandatory certification
French NF
Médical mark issued
training
(in French)
one-day
technical information sessions (in French)
|
| Recognition by third-party bodies: |
LNE/G-MED is approved by the following
accreditation bodies:
- COFRAC (France) for all voluntary company
certification
- SCC (Canada) for ISO 13485 and 13488 certification (CMDCAS
programme)
- FDA (United States) for file examination according to
510k procedure.
|
| Contact: Customer service |
