Welcome to QserveQserve® is 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 regulatory consulting company, has considerable in-house 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 project(s) from the Concept Phase, Commitment Phase, Development Phase, Transfer phase up to the Market Introduction/Surveilance. ONE STOP SHOPPING.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".
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Your "Medical Device Regulatory Compliance Consultants"
►NEW: Clinical Support Services, the approach to comply to revised MDD 93/42/EEC per March 2010.We assist you in identifying the GAPS and writing your clinical evaluation conform MEDDEV 2.7 through our in-house technical/clinical writers!
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CALL us: +31 85 7440000 or
Toll free: +1 877 288 9110 (only USA)
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Latest..NEWS
►Are you ready to comply to the revised Medical Device Directive 93/42/EEC (M5) per March 21, 2010?
Ga naar de speciale pagina:2007_47_EC (Ned)
Go to our special page:2007_47_EC (English) Call us for a GAP analysis to make sure that your company no risks encounters!
►We will be present at BIO International Convention 2010 on May 3-6 in Chicago. We welcome to visit us in the Dutch pavilion.
►Johan Bender MSc, PharmD, has been appointed as Senior Advisor. Go to his CV Johan
►We are moved back to Amsterdam.
Our new address is: Asterweg 19 D12 unit 10, 1031 HL, The Netherlands, T: +317882630, F: + 31207882631 |
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Qserve Offices EuropeT: +31 (0)20 7882630Qserve America Inc.T:
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