Service Items

IVDEAR (Shenzhen) Medical Techno

Ivdear (Shenzhen) Medical Technology Co., Ltd., subordinate to Guorui Zhongan group, is a holding subsidiary of Guorui Zhongan group. Ivdear specializes in customized regulations and registration consulting services for medical devices and in vitro diagnostic products, and provides training services for regulations and standards. Specific service areas include: EU CE certification consulting for medical devices (IVDD, MDR, IVDR), clinical experiment, ISO13485 system certification consulting, FDA registration consulting (including 510k, QSR 820, etc.) Product inspection and rectification consultation (electromagnetic compatibility, electrical safety, performance, biocompatibility, wireless, packaging test, etc.); Domestic registered nmpa consulting services (clinical scheme cro consulting services, product registration certificate consulting services, production license consulting services, import registration consulting services).

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