The first true AI intelligence engineered for Medical Device Regulatory Affairs. Navigate EU MDR 2017/745, TİTCK guidelines, ISO 13485, and FDA pathways with clinical precision.
Cygnus is directly embedded with thousands of pages of official MDR regulations, MDCG guidance, and ISO standards to provide exact, legally accurate citations rather than generic summaries.
Designed specifically to bridge the gap between EU standards and TİTCK enforcement. Seamlessly understand requirements for CE marking, UDI registration, and PMS implementation.
Cygnus learns from real-world regulatory inquiries. By interacting with the system, your anonymized queries directly contribute to the evolution of the medical device AI ecosystem over the next 6 months.