Qserve Group is a leading, independent, Dutch Medical Device Regulatory Consulting firm, with a successful track record in the Industry, since 1998. In partnership with our clients, we ensure timely global Market Access. We offer services in the areas of: Regulatory affairs, Quality affairs and Clinical Affairs.
Qserve provides market access through its offices in Europe: (Amsterdam HQ and Eindhoven), Americas (USA: Boston; Brazil: San Paulo), and Asia (China: Nanjing).
Qserve has in-house project management expertise in the areas of Life Sciences with a clear focus on Medical Devices medium/high risk, Borderline Devices, Biomaterials including Animal Tissue, Drug Release, Implant Biotechnology, IVD, Active (implantable) Devices, Electrical Safety and Medical Technology. We also have in-house expertise in product and process validation.
Additionally, we offer legal representative services: e.g. EU Authorized Representative, US Agent & US correspondent, China Legal Agent & After Sales Agent Representation, Staffing & Outsourcing, global Distributer Search, and extended Training programs through the Qserve Training Academy.