Countries

We understand your wish to market your Medical Device on the global market.

Our global team of consultants can offer you more than 500 years of experience in the field of Medical Device Regulatory Compliance. We supported our customers with over 1000 different medical devices

Areas

Our focus areas

  

Europe

We are a worldwide operating consultancy organization in the Medical Device sector with our head office in the Netherlands. We have supported hundreds of medical device manufacturers with CE marking in Europe.

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

   

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.

Qserve's legal entity can act as US Agent and Official Correspondent for all manufacturers that would like to enter the US market.

  
China

China is increasingly becoming an important playground for both domestic and international medical device manufacturers. Not only the medical device market is increasing in China, so is the complexity of the regulatory landscape.

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 (WOFE), CFDA registration or CRO services.  

Market Access

Global registration

Expanding internationally? Qserve's offices in Europe, the United States and China including our professional partner network are ready to assist you! Keep in mind that overlapping international regulations might influence your strategy. Use our knowledge and our network.

Countries

Where would you like to market your medical device?

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