Regulatory approval and clinical studies
OSYPKA is ISO 13485:2012 certified and we are on our way to be compliant to ISO 13485:2016 in the first quarter of 2019. In addition, we are FDA registered and successful audited by the FDA as contract sterilizer. Furthermore, we have a GMP certificate by ANVISA (Brazil), compliant and registered for Japan (JPAL/PMDA) and our QMS is certified for Belarus and Ukraine.
OSYPKA provides support to its OEM customers in creating technical documentation to get CE and/or FDA approval for medical devices class I – III and AIMDs.