Creating an ISO 14971 Risk Management File (RMF) is traditionally a slow, manual process involving endless spreadsheets, cross-functional meetings, and repetitive data entry. For medical device manufacturers, this often becomes the primary bottleneck delaying time-to-market.
MedMI transforms this process. Our AI-assisted Risk Management File Generator acts as a co-pilot for your regulatory and engineering teams. By simply entering your device profile and intended use, the platform instantly generates a comprehensive baseline of foreseeable hazards, hazardous situations, and associated harms.
The generated output strictly adheres to the ISO 14971:2019 framework. We use standardized P1 and P2 probability scales and universally accepted severity matrices to ensure your risk evaluations are immediately recognizable to notified bodies and FDA inspectors.
Stop starting from a blank page. Accelerate your compliance pathway, ensure consistent terminology across your risk documentation, and export audit-ready Excel matrices with a single click.
Join the regulatory teams saving hundreds of hours using MedMI's AI-assisted platform.
Built specifically to meet rigorous international standards.
Hazards, controls, and residual risks automatically linked.
Download formatted Excel files for your technical documentation.
