[ Edit this Company ] Company Profile for Qserve consultancy LLC Company Name: Qserve consultancy LLC Address: 701 – 4th Avenue South Suite 500 City, State, Zip: Minneapolis, , MN 55415 County: United States Country: US Phone: (001) 612 719 5420 Fax: (001) 612 338 0359 General Email: info@qserveconsultancy.com Web Site: http://www.www.qserveconsultancy.com Brochure: Keywords: medical device consulting, medical device consultancy, CE mark, 510k, PMA, medical devices, quality management systems ISO13485, auditing, training, clinical studies, authorized representative, desinated person, FDA experts Company Description: Qserve consultancy provides expert consulting services on regulatory submissions and quality management systems to Medical Device companies worldwide. Services Offered: Global strategic market approval (Europe and USA)n Regulatory Submissions:l Writing CE technical documentation, Design Dossier and Technical Filel Interaction with regulatory agencies during approval processl Selection of Notified Bodyl IDE, 510K and PMAl Risk analysisl Product registrations and product listing worldwide including CMDCASl Maintenance of submission documentationl Labelingn Clinical Studies:l Pre-clinical testing l Clinical study designl Clinical data auditing and monitoringl Assistance in coordination and approval of clinical studies from IRB and Ethics Committeel Post market clinical (follow up)n Quality Management Systems:l EN ISO 13485l FDA QSRl CMDCASl Risk managementn Audits:l Internal Quality Systeml Supplier and contract manufacturerl Distributorn Interim management:l Quality management systemsl Regulatory affairsn Certified Training:l EN ISO 13485l CMDCASl Medical Devices Directivesl Auditingl QSRn Special Services:l Introduction of new medical device into the (Europe and US) marketl Authorized representativel US designated agentl Update of Standards and Guidelinesl On going compliance support related to manufacturing/design issues n Process validation including softwaren Support:l On site assistancel Off site assistancel Service available in Dutch, English, German and French About Us: Qserve consultancy has a unique combination of qualified experts. Each has extensive experience and knowledge in a variety of medical device regulations and technical areas. Our mission is to guide and to manage your company’s quality and regulatory projects in the most efficient and practical ways to achieve faster registration and market approval. You can benefit from this unique approach since Qserve offers you the opportunity to create your own modular turnkey project.Competitive Advantage of Qserve consultancy Group:n Strong connections and reports with regulatory Authorities and Notified Bodies.n Resident regulatory & technical expertise in US and Europe. Differentiation: Qserve consultancy bases its services on the harmonization of practical advice and adapts its approach to the culture within a company. This approach will result in optimal acceptance of your regulatory and quality management systems by parties both internally and externally. Products Offered by Qserve consultancy LLC  No products have been listed by this company. Services Offered by Qserve consultancy LLC No services have been listed by this company. Additional Contact Information for Qserve consultancy LLC Executive Contact: Al Saalabi Executive Title: President Qserve consultancy LLC Executive Phone: (001) 612 719 5420 Executive Email: a.saalabi@qserveconsultancy.com [ About ] [ Contact ] [ Login ] © 2025 Medevnet.com - All Rights Reserved