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).

Market access

Where would you like to have market approval for your medical device or IVD?

Before you can sell your products, you need to comply with and meet global regulations. The best or most efficient route is based on your device, the different regulations, identified gaps, available budgets, and timelines.

With our global expertise on regulatory compliance and local experts everywhere, together we can determine the best strategy and effective roadmap. We fully understand complex national regulations and where they overlap. From concept to global market access, we start creating your global strategy.

 

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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 or EU-IVDR

EU Representative

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United Kingdom (UK)

Our knowledge of the MHRA ensures 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 (UKRP) and will register your devices with the MHRA.

UK market access

UK responsible person

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Switzerland (CH)

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.

EU-MDR or EU-IVDR

Swiss representative

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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

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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

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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