qServe Communications

About qServe Communications

Established in 1998 by Willibrord Driessen, Qserve Group has grown from a small team of regulatory experts into a global consultancy focused on the medical device and in-vitro diagnostics (IVD) industry. The firm operates on an international scale, with a significant presence in Europe, the United States, and China, serving a worldwide client base of medical device and IVD manufacturers. In 2014, the company saw a significant development as three new shareholders joined the Board of Directors, which currently includes CEO Jan van Lochem, Martin de Bruin, and Gert Bos.

Qserve Group's core business revolves around providing specialized consulting services designed to navigate the complex regulatory landscapes governing medical technology. The company assists clients in gaining and maintaining market access for their products by offering expertise in regulatory compliance, quality assurance, and clinical trials. Their revenue is generated through a fee-for-service model, providing tailored support that ranges from ad-hoc consulting to comprehensive project management. A key offering is their coaching-style model, referred to as "I do-We do-You do," which aims to empower clients by developing their internal expertise.

The company functions as a full-service Contract Research Organization (CRO), managing all aspects of clinical trials for medical devices, from study design and execution to post-market clinical follow-up. Their services cover a wide array of therapeutic areas, including cardiovascular, orthopedics, neurology, and wound care, for devices ranging from Class I to Class III. Qserve's team includes former staff from regulatory bodies like the FDA and EU Notified Bodies, providing clients with deep insights into compliance requirements for regulations such as EU MDR and IVDR, as well as FDA submissions like 510(k) and PMA. The firm also offers training programs and online courses for MedTech professionals to keep them abreast of the latest industry standards.