Providing certification required for the manufacturing and sales of medical devices, evaluation and testing related to the safety and quality management of medical devices, and assistance with global certification applications.
We provide total support for our customers in obtaining certifications and evaluating and testing safety and quality, including certification under the Pharmaceuticals and Medical Devices Act for medical devices, various safety assessments, ISO 13485 certification for management systems of manufacturers and distributors, traceability certification for measuring instruments used in medical device manufacturing, and support services for obtaining global certifications for overseas exports.
【Features】
■ As a registered certification body under the Pharmaceuticals and Medical Devices Act (Registration Number: AH), we conduct certifications for "Highly Controlled Medical Devices" (Class 3) and "Controlled Medical Devices" (Class 2).
■ In safety evaluations of medical devices, we conduct a wide range of product evaluations related to medical devices, including safety testing, Radio Law testing, wireless testing, electromagnetic environment testing, software evaluation, biocompatibility testing, and battery performance testing.
■ We issue valid product evaluation test reports as testing data for compliance with safety standards during certification under the Pharmaceuticals and Medical Devices Act and applications for overseas certifications (test reports can be issued with the ILAC-MRA logo).
■ For home medical devices, in addition to the safety evaluation tests under the Pharmaceuticals and Medical Devices Act mentioned above, we also conduct tests for compliance with technical standards required by the Electrical Appliance and Material Safety Act simultaneously.
*For more details, please refer to the PDF materials or feel free to contact us.
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