EN ISO 13485:2016 certification 10.12.2018


We are pleased to announce that STERISYS is further on EN ISO 13485:2016 certified.

The certification specifies requirements for a quality management system where STERISYS needs to demonstrate its ability to provide sterilisation units for medical device manufacturers that consistently meet applicable regulatory requirements.

Our ethylene oxide sterilisation units are an important key element in the medical device production process. For this reason, we want to make sure that our products are constantly audited to the latest norms and certificates.

Find our certificate here.