Raguse Gesellschaft fuer medizinische Produkte GmbH

MEDAGENT is a regulatory affairs and certification consulting firm specializing in medical device compliance and market access. Founded in 2000, the company operates with offices in Germany, USA, UK, Brazil, and Australia, serving over 300 international clients through a team of 30 regulatory experts. MEDAGENT provides comprehensive services including GMP and quality management implementation, international regulatory affairs (FDA, MDR, ISO 13485), process and software validation, compliance services, and technical documentation. The firm's proprietary digital solution FUTURA delivers MDR-compliant technical documentation as a software platform. Beyond certification, MEDAGENT supports medical device manufacturers throughout the complete product lifecycle—from concept development through market authorization and post-market surveillance—with tailored strategies for efficient market entry across multiple jurisdictions.