MTI Announcements

At Blue Goat Cyber, we specialize in medical device cybersecurity. We ensure manufacturers meet FDA, EU MDR, and global regulatory compliance while protecting patient safety. With decades of experience, we help MedTech innovators secure their devices against cyber threats and streamline regulatory approval. As we look ahead to the 2026 program year, MedTech Innovator Asia…

FormlyAI is a regulatory services company powered by AI, supporting end-to-end certification across the US FDA, EU MDR, and other jurisdictions. Led by former FDA expert Dr. Spencer Todd, the team has delivered 80+ certifications across Class I–III and AI/SaMD, producing rigorous quality documentation and audit-ready submission packages designed to reduce review iterations and accelerate…