Regulatory Services for CE-Marking and FDA submission.
Full or partial management of your regulatory activities. Award-winning 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 reviews, risk management, clinical evaluation reports (CER) and clinical studies.
MARACA International BVBA
Heirbaan 143,3110 Rotselaar