ORAVEC BIOMED

ORAVEC BIOMED is a regulatory, quality and clinical consultancy operating from Bratislava and Vienna. For medical device and IVD teams, it provides EU MDR and IVDR documentation support, gap assessment, risk management, quality-system readiness and clinical or performance evidence planning. The firm also offers authorised representative support and hands-on coordination of clinical operations, with an emphasis on audit-ready execution for companies working across Central and Eastern Europe.