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 1998, Qserve 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
Market Access
Market Access in the MedTech sector
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.
