MARACA International received the AI Acquisition International 2018 global excellence award for Recognized Leader in Quality Control Services – Belgium.
AI awarded our MARACA International focus on service excellence for our regulatory, medical, clinical and quality services to MD and IVD companies, clinical laboratories and notified bodies.
Dr. Luc Van Hove, CEO, said “we are happy receiving this AI award for global excellence”. This strengthen us in our focus on providing the best possible MARACA services to our customers.
MARACA International provides regulatory and clinical service excellence to register your MD and IVD products in Europe and the USA. We identify the gaps against the new MDR, IVDR and 21CFR. Provide training to understand these new regulations. Address the gaps in your Design Dossiers and represent you with the Notified Bodies, Competent Authorities and FDA. MARACA provides with our physician a unique CER/PER review service. Our physician can develop your PMCF/PMPF plan and assist you with your clinical studies and risk management.