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
examine product design,
carry out EC type-examinations,
approve and monitor your production quality system in
accordance with Directive Annexes,
test manufactured products for reagents specified in Annex
II list A (batch release procedure).
|
| Scope: |
All in vitro diagnostic 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 applies the most appropriate formula for batch
tests (complete or partial tests).
Regulatory precedence is systematically recognized, and
reagents already registered in France will not need to
be reassessed.
Certificates are issued for all completed conformity procedures.
Technical file examinations and audits are performed by
qualified experts who are specially
trained for each category of devices. They work
in close cooperation with a team of internationally recognized
biologists.
|
| Additional services: |
one-stop auditing for ISO 9001, EN/ISO 13485 and EN/ISO
13488 certification
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 |
