Bringing a modern medical device or digital health solution to market requires an intricate balance of human-centered engineering and complex regulatory alignment. Situated inside Nexus at the University of Leeds, our Northern UK hub sits at the direct intersection of commercial enterprise, academic brilliance, and real-world clinical practice. From early-stage workflow exploration to critical summative validation, we deliver the human factors insights required to satisfy the MHRA, FDA, and global notified bodies while keeping your end users safe.