AI-Powered Medical Device Compliance Software for EU MDR, FDA 21 CFR, and ISO 13485

Certivo’s AI-powered medical device compliance software helps streamline regulatory workflows across global markets. Whether you’re preparing for EU MDR compliance, managing FDA 21 CFR Part 820 regulations, or maintaining robust ISO 13485 documentation, Certivo simplifies the process by automating supplier document collection, regulatory updates, and audit readiness. Designed for modern medtech teams, our platform ensures faster time-to-market while reducing manual workload. Achieve full visibility and control over your compliance processes for medical devices—from initial design through post-market surveillance—with real-time insights and smart automation tools tailored to regulatory needs.