Global Regulatory Market Access for Medical Devices and IVD

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

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 CRO 

EU Representative

United Kingdom (UK)

Our Knowledge of the MHRA ensures that we can support you with an efficient regulatory strategy for your medical device or In Vitro Diagnostic. Qserve can act as your UK Responsible Person and will register your devices with the MHRA.

UK Market Access

UK Responsible Person

Swiss Authorised Representative

Swiss is a third country as of May 26, 2021. Manufacturers must designate a Swiss authorised representative to supply devices to Switzerland in accordance with the transition plan.

Swiss Representative

United States

Since 1998Qserve has served as an official US Agent for over 200 medical device and IVD companies from 20+ countries worldwide. Our Knowledge of the US FDA ensures that we can support you with a cost-effective regulatory strategy.

US Market Access

US Agent

China

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

China Market Access

China Agent

Global Registrations

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

 

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