MARACA International, located in Belgium, the heart of Europe, offers a complete list of services to assist the manufacturer in obtaining the CE-mark and or FDA approval for his products. MARACA provides regulatory, medical and clinical services to Pharma, Medical Device and Invitro Diagnostic Device companies, clinical laboratories and notified bodies.
Regulatory Services for CE-Marking and FDA submission
Full or partial management of your regulatory activities. General consulting and training on the new MDR and IVDR Regulations, the US 21CFR regulations and their impact on your business. Composition or review of your design dossier for NB assessment or third party FDA review. Review of your IFU and product labels. Advise in the design of labeling and Unique Device Identifier (UDI). Gap analysis of your quality system versus the requirements of the MDD/MDR or IVDD/IVDR Regulation, or the 21CFR 820 and ISO13485. Advice in the classification of medical devices, IVDs, software and health applications. Composition of performance evaluation plans and reports. Organization of clinical performance evaluation studies. Your ambassador with NB, CA, FDA, CFDA interactions and submissions. Management of incidents: Health hazard assessment, incident notification, recall and advisory notices.
Unique service as medical Practitioner for Design Review, Risk-Benefit Summary, Health Hazard Assessment, Clinical Evaluation Report (CER), Clinical study protocols & reports and Ambassador to NB & FDA.
For Performance Evaluations, we offer Scientific Validity Reports & Clinical Validity Reports with Lit. review; Clinical Evaluation Reports (CER) with Lit. review & Gap analysis; Clinical Investigation Plans & Reports and PMCF Plans and Reports.
MARACA International BVBA
Heirbaan 143,3110 Rotselaar