About Us
AQC TECHNICAL ASSESSORS (M) SDN. BHD. is approved as a Conformity Assessment Body (CAB) by Medical Device Authority – Ministry of Health Malaysia with CAB registration number MDA/CAB-022.
Our assessment professionals provide assessments and verification on Medical Devices with stringent quality with adherence to relevant Malaysian regulatory requirements .
AQC TECHNICAL ASSESSORS (M) SDN. BHD. provides certification based on
– Medical Device Quality Management system (MDQMS) – ISO 13485:2016,
– Good Distribution Practice for Medical Devices (GDPMD) and
– MDA Registration for Medical Devices Active & In-Vitro Diagnostic (IVD) Product Conformity
for Medical Device Manufacturers, Authorised Representative (AR) of overseas Manufacturers, Medical Device Importers, Distributors within Malaysia region.
ATA Assessors are expertised Doctors, Medical industry professionals and Biomedical Engineers. Our professionals are highly experienced with various manufacturing and servicing on medical devices. Our adherence to regulatory requirements on Medical devices assessments and verification are trusted and recognized as credible in Malaysia.
Our Vision
To be the trusted conformity assessment service provider on certifying Medical Device’s compliance towards applicable Regulatory Adherence.
Our Mission
To assess Medical Device’s conformity and certify by adhering to applicable compliance in a quality way thereby uplifting the trust of medical device users.
Our Impartiality Policy
AQC Technical Assessors Sdn. Bhd.’s committed for its assessment and certification services, in an open, independent and impartial manner. Everyone who utilizes AQCTA certified client/s might rely on this impartiality and objectivity based on their individual concluded decisions.
Our certification decisions are uniquely based on the objective evidence obtained in an impartial manner, and are assessed, managed if any conflicts of interest that possibly arise.
Each AQCTA clients are approached and considered in a controlled impartial manner, so that each of them achieve the same expected level of performance for obtaining and maintaining AQCTA certification.
Our Confidentiality Policy
AQCTA is committed in safeguarding the confidentiality of information created, accessed, obtained, stored, transferred through its interested parties.
ATA maintains all information from its activities, as confidential, and doesn’t make it available to general public or applicable interested parties, without the knowledge of relevant client / individual, except for those ATA personnel who are directly involved in carrying out ATA duties.
ATA intend to maintain and make public upon request on any interested party information and will disclose information regarding the granted, suspended, withdrawn certifications as per the norms set out.
ATA client’s and interested party’s confidential information shall be disclosed under circumstances where regulatory and/or accreditation body and any laws or regulations that require it for any purpose, and the same will be notified to the concerned where their information is disclosed”