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.
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
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
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
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
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 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