Welcome to Qserve®Qserve is ISO 9001:2008 registered, acting as an independent MEDICAL DEVICE CONSULTING firm operating worldwide, with extensive Regulatory Compliance Experience having offices in Europe (the Netherlands) and the United States, since 1998. Qserve, as medical device consulting company, has considerable in-house regulatory affairs expertise in the areas of medical device regulatory affairs, strategic approach, due diligence & GAP analysis, CE -MARKING, PMA & 510(k) & US -agent, international product compliance, clinical evaluation, certified training, and quality management systems (ISO 13485) implementation. Our experienced project managers manage your medical device projec(s) from the Concept Phase, Commitment Phase, Development; Phase,Transfer phase up to; the Market Introduction and Post Market (Clinical) Surveillance Phases. Our ONE STOP SHOPPING services. We are very familiar with a wide range of MEDICAL DEVICES, especially HIGH RISK, COMBINATION and BORDER LINE Medical Devices, for a detailed overview please view our:"Project Portfolio". We brought more than 200 medical device companies, from Start-up to Multi Nationals, with their medical device products to the market. More about us, the practical approachWe moved back to Amsterdam! |
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Your "Medical Device Consultants"
►NEW: Clinical Support Services, the approach to comply to revised Medical Device Directives, March 21, 2010. We assist you in identifying the GAPS and writing your clinical evaluation reports conform MEDDEV 2.7, through our in-house technical/clinical writers!
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CALL us: +31 85 744 0000 or
Toll free: +1 877 288 9110 (only USA)
Our brochure: EAR LEAFLET
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Latest..NEWS
►We are happy to announce that the divisions of Qserve Group BV , obtained their ISO 9001:2008 certification; one of the first Regulatory Compliance Consultancy companies in Europe.
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►Our Medical Device Training courses schedule has been updated with new courses!
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Qserve Offices EuropeT: +31 (0)20 7882630Qserve America Inc.T:
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