Global Regulatory Market Access for MDR and IVDR

Qserve is your one partner for worldwide regulatory compliance for medical devices (MDR) and In-vitro diagnostics (IVDR)

Where would you like to have market access?

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

Switzerland (CH)

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Switzerland is a third country as of May 26, 2021. Manufacturers must designate a Swiss authorized 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

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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

Rest of the World

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