Qserve Group

Qserve Group is a specialized regulatory consulting firm founded in 1998, focused exclusively on medical devices and in-vitro diagnostics (IVD). With offices across the United States, Europe, and China, the company provides regulatory affairs, quality assurance, and clinical trial support to medical technology manufacturers worldwide. The firm has documented over 750 successful MDR submissions and 500 FDA 510(k) approvals.

The company's consultant team includes engineers, scientists, and clinicians with direct industry experience from regulatory, R&D, and quality roles. Qserve provides services spanning the complete product lifecycle, from strategic regulatory planning and clinical evaluations to quality system implementation, post-market surveillance, and regulatory due diligence for mergers and acquisitions. The firm maintains established relationships with notified bodies and regulatory authorities.

Qserve operates a proprietary regulatory intelligence tool called Qserve InSight and has launched Qserve Learn, an online training platform for medical device professionals. The company employs staff across seven global offices and maintains client relationships with major medical device manufacturers including Abbott, Medtronic, and Philips.

Choose Qserve Group when you need demonstrated expertise in medical device regulatory compliance across multiple jurisdictions, particularly for complex scenarios involving EU MDR/IVDR transitions, FDA submissions, or global market expansion. The firm's consultant team brings practical implementation experience from industry roles rather than theoretical guidance.

Expect a lifecycle approach where regulatory strategy aligns with business objectives. The company's established relationships with notified bodies and regulatory authorities can facilitate smoother approval processes, while their M&A due diligence capabilities support strategic transactions in the medical technology sector.

Qserve Group operates exclusively within the medical technology sector, serving manufacturers of medical devices and in-vitro diagnostics. The firm's healthcare focus centers on regulatory compliance for physical medical products rather than digital health, pharmaceuticals, or healthcare services. Their expertise spans therapeutic areas including cardiovascular, orthopedic, diagnostic, and surgical devices.

The company maintains specialized knowledge of healthcare-specific regulatory frameworks including FDA requirements, EU MDR/IVDR regulations, and China NMPA processes. Their services directly support patient safety objectives by ensuring medical devices meet regulatory standards before market entry and maintain compliance throughout the product lifecycle.

Medical device and IVD manufacturers with products requiring multi-market regulatory approval, including both established companies managing regulatory portfolios and growth-stage firms navigating initial submissions. Companies undergoing M&A activity or those transitioning legacy products to new regulatory frameworks (MDR/IVDR) represent strong fits.