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 Affairs, Quality Assurance, Clinical Affairs, Clinical Trials, Training, and Auditing.

 

 

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

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 Agent (Qserve has a local entity in China (WFOE), CFDA registration or CRO services. 

China 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