|
Quality system
|
The quality is one of the main interest of our mission. It is reflected in each of our procedures. Our objective is to assure that every batch of product is treated according to the strictest standards. We make a commitment to offer a service which answers completely safest standards, traceability of products and efficiency. The quality system is based on written procedures (SOP) and working instructions (WI).
All our services answer the standards and following certifications: ISO 11135-1, ISO 13485, ISO 17025, ISO 9001:2008, FDA, CE mark.
|
 |
Certificates
Certificate ISO 13485:2003 + AC:2007 (Sterilization of medical devices on the basis of ISO 11135:2007) (PDF English) Certificate ISO 13485:2003 + AC:2007 (Kit packing and distribution of medical devices) (PDF English) Certificate ISO 13485:2003 + AC:2007 (Manufacture) (PDF English) Certificate ISO 9001:2008 (PDF English) Japan Registration (PDF English) FDA Registration (PDF English) Certificate Swissmedic (PDF) Certificate ISO 17025 (PDF) CE mark - Annexe V (PDF English) CE mark- Annexe V Class Im (PDF English) CE mark - Annexe V Class Is (PDF English)
Consulting
Advise to improve manufacturing process Assistance on the product development Assistance during audits Define protocol, worst case analysis
Training
Specific training on environmental monitoring, validation, sterilization Update on the new standards Organization of seminars
|