Tuffclassified

Bringing a medical device to market demands more than just clinical execution — it requires a partner who truly understands the science, regulations, and realities of the medical device industry. We are a full-service, medical device–focused CRO dedicated to supporting manufacturers through every phase — from clinical strategy and regulatory submissions to post-market follow-up. Why Leading Device Companies Choose Us: Deep expertise across Class I to III devices Proven success with EU MDR, FDA, and global regulatory requirements Efficient patient recruitment and site management tailored for device studies Integrated data management and quality systems ensuring audit-ready results Flexible, transparent collaboration built around your timelines and goals Whether you’re a startup preparing your first clinical investigation or an established manufacturer expanding globally - we bring the experience, infrastructure, and commitment to make your trial a success the first time.