Certificates

CE Certificate	CE Certificate (2)	EN ISO 13485:2003+AC 2007	EN ISO 11135-1:2007 (2)	EN ISO 9001:2008	EN ISO 9001:2008 (2)

Suture surface control		Electronic sterilization management unit		Stability research and management unit

Suture tensile strength testing device

• Manufacturing acitivities are carried out in strictly Class 10,000 and Class 100,000 clean rooms
• All of our clean rooms are INDEPENDENTLY VALIDATED by accredited European Institutions
• Our sterilization process is also fully validated by independent European Testing companies and EN 550 certified
  by German TÜV Rheinland.
• Biological Validation
• Physical Validation and Performance Qualification
• Software Validation
• All of our suture winding cartons are chlorine and acid free

In our company, ISO 9001 and similar quality systems are regarded and used as an effective management development tool rather than a road to certifications. With the implementation of "total quality" principles at SSM, we have been able to reach productivity levels comparable to world leader companies in our sector.

Today our scrap rates are probably one of the lowest in the world.Our continuous efforts to improve process efficiencies are a part of industrial engineering research activities and our management's strong commitment to create world-class high quality products with excellent price/benefit ratio.

To ensure the testing abilities of our own laboratories, we periodically send samples to accredited independent European institutions from our products. Our clean-rooms and sterilization processes are also validated by independent institutions, including the software validations in line with requirements of ISO 13485.

Our strong commitment to "high quality" is influencing our purchasing policies significantly. We are extremely meticulous about choosing our suppliers especially among the ones who have internationally recognized quality certificates such as ISO 9001, CE mark or FDA approval.