Qserve Group

Business Consulting and ServicesGelderland, Netherlands51-200 Employees

Qserve Group operates in the MedTech regulatory, clinical, and quality compliance space and provides full-service CRO support for medical device clinical trials. Headquartered in Arnhem, Gelderland, the Netherlands, the company is located at 310 Utrechtseweg and employs between 51 and 200 people. The firm maintains an international footprint across Europe, China, and the United States to help manufacturers achieve global market access for medical devices and in vitro diagnostics. Its service portfolio covers Regulatory Affairs, including EU MDR and IVDR, FDA compliance, CE marking, and submissions; Clinical Affairs and CRO services, including trial design and execution, evaluations, and post-market activities; Quality and Compliance, such as QMS implementation, audits, and training; and Global Representation, including US Agent, EU Representative, UK Responsible Person, and China Agent for NMPA registration. The company focuses on regulatory navigation, clinical strategy support, and ongoing compliance to support medical device market access.

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