2 Services

compliance

compliance

At confinis, our compliance services are designed to ensure your medical devices meet rigorous regulatory standards across various markets. Whether you are navigating the complexities of MDR Article 117 for combination products, aiming for IVDR conformity, or seeking market authorization in Europe, the USA, or other global markets, our expert team provides comprehensive support. We specialize in design control, risk management, usability engineering, and clinical evaluation. From CE marking and FDA registrations to performance evaluations and software considerations, confinis is your trusted partner in achieving and maintaining compliance, facilitating a smooth and efficient route to market for your innovative healthcare solutions.