Audit History
2019
- UKRAINE – Ukrainian Center for Medical Certification and prognostication
- USA – FDA
- ITALY – Notified Body n. 0546 for UNI EN ISO 9001:2015 certification & UNI CEI EN ISO 13485:2016 certification + medical device CE certification
2018
- UKRAINE – Ukrainian Center for Medical Certification and prognostication
- CHINA – CFDA
- UKRAINE – ECOHYNTOX Conformity Assessment Body
- ITALY – Notified Body n. 0546 and n. 0373 for UNI EN ISO 9001:2015 certification & UNI CEI EN ISO 13485:2016 certification
2017
- G.C.C. – SGH_ Saudi Arabia
- UKRAINE – Ukrainian Center for Medical Certification and prognostication
- BRAZIL – Brazilian Health Surveillance Agency
(ANVISA) - ITALY – Notified Body n. 0546 for UNI EN ISO 9001:2008 certification & UNI CEI EN ISO 13485:2012 certification
Notified body n. 0373 for Class III Medical Device CE certification
2016
- ITALY – Notified Body n. 0546 for UNI EN ISO 9001:2008 certification & UNI CEI EN ISO 13485:2012 certification