MDSAP is a certification syste..
MDSAP is a certification system established by the International Medical Device Regulatory Forum (IMDRF) for joint revi..
Currently, MDD was abolished i..
Currently, MDD was abolished in 2017 according to MDR 2017/745 through many changes and customer-oriented thoughts and..
Medical Device Quality Managem..
Medical Device Quality Management System Certification Specification, ISO 13485ISO 13485 : Specifies the requirements o..
European agent (Authorized Rep..
European agent (Authorized Representative) is a natural or legal person within EC region, expressly appointed by a man..
U.S. FDA Medical Device 510(k)..
U.S. FDA Medical Device 510(k) Approval510(k), also called Pre-marketing Notification (PMN), is the article number of t..
Any business outside the US in..
Any business outside the US involved in manufacturing, packaging, proliferation, compounding, or processing of any medi..
MTGS (Medical Total Solution S..
MTGS (Medical Total Solution Solution) will provide interpretation and translation services with our experiences in co..
In order to issue a test repor..
In order to issue a test report of electrical and mechanical safety test (IEC 60601)Risk Management ReportSoftware Vali..
Medical device companies must ..
Medical device companies must comply with the MDR to legally manufacture, import, and distribute the products in CanadaM..