Qserve Group Information

Qserve is a trusted global partner for MedTech Regulatory, Clinical, and Quality Compliance, as well as a full-service CRO for medical device clinical trials. With a strong international presence in Europe, China, and the United States, our team of experts combines deep regulatory knowledge with hands-on industry experience to help manufacturers achieve global market access for all types of medical devices and in vitro diagnostics (IVDs). We provide strategic guidance and tailored support across a wide range of services, including: - Regulatory Affairs. EU MDR, EU IVDR, FDA compliance, global regulatory strategy, CE marking, Pre-IDE, PMA, 510(k) submissions, and global medical device registration. - Clinical Affairs & CRO Services. Clinical trial design and execution, clinical evaluations, post-market clinical follow-up, and regulatory due diligence. - Quality & Compliance. Quality management system implementation, gap analysis, audits, and training. - Global Representation. US Agent, EU Representative, UK Responsible Person, and China Agent for NMPA registration. Whether you're navigating complex regulatory landscapes, optimizing clinical strategies, or ensuring compliance, Qserve is your dedicated partner in bringing innovative MedTech solutions to market.