Audit History
2022
- ITALY – Istituto Superiore di Sanità
- UKRAINE – ECOHYNTOX Conformity Assessment Body
2021
- ITALY – Istituto Superiore di Sanità
- UKRAINE – ECOHYNTOX Conformity Assessment Body
- ITALY – Notified body n. 0546 for ISO 9001:2015 & ISO 13485:2016 certifications + maintenance of the approval of the CE certificate 11971/2
- KAZAKHSTAN – National Center of Expertise of Drugs and Medical Devices
- ITALY – Certification of Quality System according to Directive 93/42/EEC + approval of the CE certificate n. EPT 0477.MDD.21/4446
- UKRAINE – Ukrainian Center for Medical Certification and prognostication
2020
- ITALY – Notified body n. 0546 for ISO 9001:2015 & ISO 13485:2016 certifications + maintenance of the approval of the CE certificate 11971/2
- UKRAINE – Ukrainian Center for Medical Certification and prognostication
- UKRAINE – ECOHYNTOX Conformity Assessment Body
2019
- UKRAINE – Ukrainian Center for Medical Certification and prognostication
- ITALY – Istituto Superiore di Sanità
- UKRAINE – ECOHYNTOX Conformity Assessment Body
- ITALY – Notified body n. 0546 for UNI EN ISO 9001:2015 & UNI CEI EN ISO 13485:2016 certifications + medical device CE certification
- USA – FDA
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 & UNI CEI EN ISO 13485:2016 certifications
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 & UNI CEI EN ISO 13485:2012 certifications
- ITALY – Notified body n. 0373 for Class III Medical Device CE certification
2016
- ITALY – Notified body n. 0546 for UNI EN ISO 9001:2008 & UNI CEI EN ISO 13485:2012 certifications