Visit our stand in Hall 3, FIT 3J74 with your questions about the registration in Europe and the USA of your medical devices or in-vitro diagnostic devices. MARACA International can help you prepare for the new Medical Device Regulation and the new IVD Regulation or for the US 21CFR. We can train you, identify the gaps and help you close these gaps. MARACA can help develop your Design Dossiers or Technical Files. Assist you with your design control, risk management and clinical validation activities. A unique service by our inhouse physician is your design dossier review and Clinical Evaluation Report/Performance Evaluation Report development and sign off. Our physician can help also with your clinical validation studies and Post-Market Clinical Followup studies. As physician he is uniquely positioned to represent and defend you with the NB, CA and FDA.