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CE Marking and Dossier Preparation: MDCPartners has extensive experience in conformity to the Medical Device Directives (MDD, IVDD and AIMD), the expectations of notified bodies and competent authorities. Our company offers a range of pre-audit services that prepare our clients for CE certification. We can act on behalf of manufacturers located outside the European Economic Area as the authorised representative, a legal requirement for placing CE marked products on the market. Feasibility for clinical trials MDCPartners with the help of the internal data mining tools and complementing research can facilitate and support your country or regional tral feasibility needs. We have experience in the area of CNS and oncology. Training in regulatory processes MDCPartners offers focused and tailored educational support in the area of regulatory affairs, CE marking, standardisation of medical devices. Access to market for medical devices The last hurdle to market is often the cost evaluation and reimbursement process. Through in-house expertise and our network of consultants in Europe, MDCPartners can evaluate the national approval process for your device and guide the submission and negotiation procedure. For more information on any of these topics, contact Mireille De Cré by mail ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it ) |