Welcome to Qserve®

Qserve, ISO 9001:2008 registered, is a leading independent MEDICAL DEVICE REGULATORY CONSULTING firm operating worldwide, with extensive Scientific & Regulatory & Clinical compliance experience, having offices in Europe, Americas and Asia since 1998.

Qserve, as a medical device (Life Science) consulting company, has considerable in-house Regulatory Affairs and Scientific Expertise in the areas of medical device regulatory affairs, Strategic Planning, Project Management,Due Diligence & GAP analysis, CE-Marking, Pre-DE, -PMA & 510(k)&USAgent and Official Correspondent , Software validation (Imaging), Electrical Safety (IEC 60601 3e edition , Global Regulatory Product Compliance, Clinical (CRA) Affairs, Certified Training, Quality Management Systems (ISO 13485) implementation and Medical Technology in the Health Care (Medische Technologie in de Zorg).

We have worked with more than 200 medical device companies, from Start-ups to Multi Nationals, to bring successfully their medical device products to the Medical Device market.

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More about us, the practical approach