Assessed, Verified For Acceptance, Trust, Credibility, Quality
AQC TECHNICAL ASSESSORS (M) SDN. BHD.
Conformity Assessment Body (CAB) approved by “Medical Device Authority – Ministry of Health Malaysia” with registration number MDA/CAB-022.
Medical Device Quality Management system (MDQMS) ISO 13485:2016
Good Distribution Practice for Medical Devices (GDPMD)
Conformity Assessment by Way of Verification (CoAWOV)
AQC TECHNICAL ASSESSORS (M) SDN. BHD.
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.
AQC TECHNICAL ASSESSORS (M) SDN. BHD. Services
Why choose
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CAB by Medical Device Authority (MDA) from Ministry of Health Malaysia
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ISO 13485 Certification, GDPMD, Conformity Assessment of Technical Documentation, Conformity Assessment by Way of Verification
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MDA approved 22 Specialised Technical Codes on Medical devices and InVitro devices
[MD 0103, MD 0104, MD 0105, MD 0106, MD 0106, MD 0108, MD 0301, MD 0303, MD 1102, MD 1103, MD 1105, MD 1107, MD 1108, MD 1109, MD 1402, IVD 0101, IVD 0102, IVD 0103, IVD 0201, IVD 0202 , IVD 0203, IVD 0301, IVD 0302, IVD 0303, IVD 0305]