 Production environment :
Class 1000 clean room (ISO 6)
Class 100 Laminar Flow (ISO 5)
Raw material :
Silicon Platinum cured only
Applications Class I , II , III devices , for human body
implantation + or - 29 days
 Thermoplastic USP Class VI quality
Applications Class I , IIa devices, for human body
implantation less than 29 days
Manufacturing process :
Extrusion (catheter, sheath, probe, etc…) , Moulded
parts according to drawing , Over-moulding (gripon titanium
or stainless steel, etc…) , Dipping, Calandering, Coating,
...
 Every operating ways come from our general processing procedure,
adapted to Quality Management Plans established with the customer,
and this for each product.
Applications :
-
Digestive surgery
- Plastic surgery
- Cardiovascular
- Nutrition
- Drainage
- Gastroplasty
We are able to meet your needs not only for surgical or medical
implant, short or long term, but as well for biomedical, pharmaceutical
applications and others, always with certified compounds, and
in ultra protected processing environment.
We guarantee our productions certified according to ISO 9001
versus 2000 & ISO 13485:2001 standards.
A range of CE marked products is as well available.
We keep on your disposal our experience and knowledge, as
well our R&D department, to study your projects together
with you. We can establish together your specifications, and
a confidentaility agreement for each project.
Our will is to help you going ahead with your projects and
ideas, and carrying them out. |
