Established from 2019 in Malaysia, we are approved as a Conformity Assessment Body (CAB) by Medical Device Authority – Ministry of Health Malaysia with CAB registration number MDA/CAB-022.

ATA’s talented professionals provide assessments and verification on Medical Devices (In-vitro, In-vivo) with stringent quality and approvals based on relevant Malaysian regulatory requirements.

AQC TECHNICAL ASSESSORS (M) SDN. BHD. provides certification based on
– ISO 13485:2016 – Medical Device Quality Management system (MDQMS)
– GDPMD – Good Distribution Practice for Medical Devices
– Conformity Assessment of Technical Documentation
– Conformity Assessment by way of verification
for Medical Devices that are Active, Non-Active & In-Vitro Diagnostic (IVD) etc in nature.

ATA’s customer includes Medical Device Manufacturers, Authorised Representative (AR) of Manufacturers, Medical Device Importers, Distributors within Malaysia region.