MDEXT
A
(1416447-H)
ASEAN Medical Device Certification Centre
is a Conformity Assessment Body (CAB) registered with the Medical Device Authority (MDA),Ministry of Health,Malaysia and provides Medical Device & QMS Certification.It is a trusted certification centre, dedicated to ensuring products, systems, and processes meet the highest standards of quality, safety, and regulatory compliance.
MDEXT
A
About Us
Our Mission
Our mission at the ASEAN Medical Device Certification Center is to establish the highest standards of quality & safety for medical device certification. We strive to promote the advancement of medical technology by providing thorough assessments & evaluations that comply with internationally recognized standards
Our Vision
Our vision at the ASEAN Medical Device Certification Center is to become globally recognized leader in medical device certification , driving the advancement of medical technology & enhancing patient outcomes worldwide.
Services
Medical Device Certification
Our services include conformity assessment through technical documentation & by way of verification,ensuring compliance with regulatory requirements and international standards.
Quality System Certification
Our certification process involves a comprehensive assessment of our clients’ systems to ensure compliance with ISO 13485:2016 and GDPMD standards.
Medical Devices Inspection Program
We offer inspections program in healthcare institutions for Maintenance Management of Active Medical Devices based on MS2058:2018, Testing & Commissioning based on MS2739, & Disposal based on MS2650, all in accordance with the latest standards.
Our inspections help ensure that healthcare institutions comply with the regulatory requirements & industry standards to ensure safety & performance of medical devices.
Training Programme
We offers a range of training programs for the medical device industry, including Regulatory Training, ISO13485:2016 and GDPMD, Maintenance Documentation based on MS2058:2018, T&C Documentation based on MS2739:2021, Disposal of Medical Devices based on MS2650:2015, & Maintenance Monitoring based on ISO17020.
Our experienced trainers offer comprehensive training programs designed to help our clients achieve & maintain the highest levels of quality & safety in the medical device industry.
List of trainings:
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ISO13485:2016
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GDPMD
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Regulatory training on EPSP,CSDT,CER, Usability Engineering,
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Implementation of Maintenance Management based on MS2058:2018,
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Implementation of T&C Documentation based on MS2739:2021,
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Implementation of Disposal of Medical Devices based on MS2650:2015, &
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Risk Management based on ISO14971:2016
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Maintenance Monitoring based on ISO17020.
Resource Centre
