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STERISYS is certified according to EN ISO 13485:2016

Once again this year, STERISYS has successfully passed the surveillance audit for the ISO standard EN ISO 13485:2016.

[Translate to English:]

EN ISO 13485:2016 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices and therefore plays an important role, especially for the medical technology industry. 

As part of a surveillance audit, STERISYS was audited for compliance with the standard by TÜV Rheinland on April 27-28. Thus, the existing EN ISO 134885:2016 certificate was confirmed with "no findings" for another year.

If you have any further questions on this subject, we look forward to hearing from you.