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| Suture
surface control |
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| Electronic
sterilization management unit |
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- 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.
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| Stability
research and management unit |
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| Suture
tensile strength testing device |
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