AMDEXT
ASEAN Medical Device Certification Centre
About Us
We are a team of medical device technical experts that provide independent & reliable certification & accreditation services to the medical device industry. We uphold the highest standards of safety, effectiveness, & quality for medical devices by rigorously adhering to industry standards and leveraging our expertise.
Our Mission
Our mission at the ASEAN Medical Device Certification Center is to establish the highest standards of quality & safety for medical devices through certification & accreditation. We strive to promote the advancement of medical technology by providing thorough assessments & evaluations that comply with internationally recognized standards. Our unwavering commitment to achieving these goals is a testament to our dedication to supporting the healthcare industry & improving the lives of patients worldwide.
Our Vision
Our vision at the ASEAN Medical Device Certification Center is to become a globally recognized leader in medical device certification and accreditation, driving the advancement of medical technology & enhancing patient outcomes worldwide. We strive to establish the highest standards of quality & safety in the medical device industry, and our dedication to innovation & excellence motivates us to continually enhance our services & remain at the forefront of industry developments.
Services
Medical Device Certification
We provide expert assessment of medical devices' safety & performance for the medical devices industry. Our services include conformity assessment through full assessment of technical documentation & by way of verification, ensuring compliance with regulatory standards. Our team of experienced professionals helps clients to ensure their products meet the highest levels of quality and safety.
Quality System Certification
Our company specializes in providing certification services for quality management systems in medical device establishments. 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.
