Global Regulatory Market Access Medical Devices and IVDs

Qserve is your one partner for worldwide regulatory compliance for medical devices (MD) and in-vitro diagnostics (IVD).

Market access for medical devices and IVD's

Navigating Market Approvals for Medical Devices and IVDs

Where do you envision obtaining market approval for your medical device or IVD? In order to launch your products successfully, compliance with global regulations is essential.

The optimal and most efficient approach hinges on factors like your device's characteristics, diverse regulatory requirements, identified gaps, available resources, and timelines.

Benefit from our worldwide regulatory proficiency and tap into local expertise across the globe. Together, we can chart a course towards the best strategy and a roadmap that delivers results. We possess a comprehensive understanding of national regulations and their intersections. Starting from the initial concept to achieving global market access, we're dedicated to crafting your global strategy. Market Access/US.jpg?preset=content

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

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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.


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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

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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.


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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

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Global Medical Device Registration

Qserve is your trusted partner in the medical device industry, providing comprehensive solutions for global market access. With a dedicated team of experts and a deep understanding of international regulations, we streamline the process of medical device registration. Our mission is to ensure your product's quality and safety, so you can confidently bring it to the global market.

Global Medical Device Registration 

Why Choose Qserve for your Global Market Access? 

Global Expertise: Our team of experts from around the world, each with a profound knowledge of local and global regulations. We've got a deep understanding of the nuances within various markets, ensuring your device is ready for a successful launch.
Compliance Assurance: We eliminate the uncertainty surrounding regulatory compliance. Qserve's in-depth understanding of international regulations means your medical device will meet all the necessary requirements.
Quality and Safety: The paramount focus lies on the quality and safety of your product. Qserve works diligently to guarantee that your medical device not only complies with regulations but also meets the highest quality and safety standards.
Streamlined Process: We understand the complexities of the registration process. Qserve streamlines the path to global market entry, saving you time and resources so you can focus on innovating and improving healthcare.

Contact us today to begin your journey toward successful global medical device registration with Qserve.

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