Artificial intelligence (AI) is revolutionizing the medical device industry, but it also brings new regulatory challenges. At confinis, we help clients navigate the complexities of regulated AI, ensuring that their AI-based devices comply with regulatory standards. Our services include AI risk management, validation, and regulatory strategy development.

We provide guidance on designing and validating AI algorithms, ensuring that they are transparent, reliable, and safe. Our team helps clients understand the regulatory requirements for AI, such as those outlined by the FDA and the European Commission, and develop strategies to meet these requirements. By leveraging our expertise in regulated AI, clients can bring innovative AI-based devices to market while ensuring compliance and patient safety.