Welcome to Qserve®
Qserve, ISO 9001:2008 registered, is a leading independent MEDICAL DEVICE REGULATORY CONSULTING firm operating globally, with extensive Scientific & Regulatory & Clinical compliance experience,. Qserve has offices in Europe (HQ in Amsterdam), Americas (USA: Boston, Washington, New Jersey and New Hamphire Area), Brazil and Asia (China) 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), US Agent 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) , Audting (FDA Mock) 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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