Regulatory approval and clinical studies

OSYPKA is ISO 13485:2016 certified. 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 (MDR) and/or FDA approval for medical devices class I – III and AIMDs.