A
MDEXT
(1416447-H)
ASEAN Medical Device Certification Centre
Registered with the
Medical Device Authority (MDA),
Ministry of Health,Malaysia
"Your Trusted
Medical Device & QMS
Certification Centre"
Amdext is a Conformity Assessment Body (CAB) registered with Medical Device Authority( MDA) , Malaysia. It is a trusted certification centre, dedicated to ensuring products, systems, and processes meet the highest standards of quality, safety, and regulatory compliance.
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.
RESOURCE CENTRE
