Sphinx Tools Ltd.:
The highest quality for the highest precision

We not only promise top quality – we provide it, with strict controls, full traceability and independent certification.

Our quality management system is multiply certified – to ISO 9001:2015, EN ISO 13485:2016 as well as FDA registration: 3010871687. Therefore Sphinx stands for highest quality and a worldwide service. We fully meet the customers' requirements – thanks to repeatable quality, clear specifications, distinct procedures and total traceability.

Our procedures are multiply secured, for example by means of the following process stages:

  • ISTR = Initial Sample Test Report
  • P-FMEA = Potential Failure Mode and Effects Analysis 
  • Customer-specific tests and specifications

For medical technology we do the cleaning and packaging in accordance with GMP (Good Manufacturing Practice) – in an approved clean room of category 8, ISO 14644-1.



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