MARACA International has received the AI Acquisition International 2018 global excellence award for Recognised Leader in Quality Control Services.
AI awarded the company for focusing on service excellence in its regulatory, medical, clinical and quality services to medical devices (MD) and in-vitro diagnostics (IVD) companies, clinical laboratories and notified bodies.
MARACA’s CEO Dr Luc Van Hove said: “We are happy receiving this AI award for global excellence”.
The award strengthens MARACA in its focus to provide the best possible MARACA services to its customers.
MARACA International provides regulatory and clinical service excellence to register MD and IVD products in Europe and the US. It identifies the gaps against the new Medical Device Regulation (MDR), In-Vitro Diagnostics Regulation (IVDR) and Title 21 in the Code of Federal Regulations (CFR).
The company provides training to understand these new regulations, addresses the gaps in design dossiers and represents its clients to notified bodies, competent authorities and the US Food and Drug Administration (FDA).
MARACA also provides a unique comparative effectiveness research (CER) review service, and its physician can develop post-market clinical follow-up (PMCF) plans and assist with clinical studies and risk management.