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            Market Access

            Our primary focus is on medical device and In-vitro diagnostics making Qserve your one partner for worldwide regulatory compliance

            MARKET ACCESS

            Market Access

            We are a worldwide operating consultancy organization in the MedTech sector. We have supported hundreds of medical devices and In Vitro Diagnostics manufacturers with Global Market Access. We are highly specialized in Regulatory, Quality Affairs, Clinical Trials, and Training.

             

             

            AREAS

            Our focus areas

            Europe

            Our knowledge of the European Medical Device Regulation and European In Vitro Diagnostics Regulation ensures that we can support you with an efficient regulatory strategy for your medical device.

            EU-MDR EU-IVDR

            United States

            We have supported hundreds of medical devices with FDA submission. Our Knowledge of the US FDA ensures that we can support you with a cost-effective regulatory strategy.

            US Market Access

            China幸运彩计划注册

            Qserve can help you navigate through the Chinese market by offering a wide range of customized services, including building regulatory strategy plan, Clinical Affairs, CFDA China幸运彩计划注册 Agent (Qserve has a local entity in China幸运彩计划注册 (WFOE), CFDA registration or CRO services. 

            China幸运彩计划注册 Market Access

            Global registration

            Working with a global team of experts, Qserve manages a diverse array of projects in the medical device industry. Together, we bring your medical device to the global market, complying with international regulations and assuring product quality and safety.

            Global Registration

            How can we help you? Contact us