[Single Analysis] AIRA – AI-Powered Risk Analysis for Medical Devices

AIRA supports risk analysis for medical device manufacturers – structured, audit-ready, and fully aligned with ISO 14971 and EU MDR requirements.

Risk analysis under ISO 14971 is time-consuming and methodology-sensitive. SIFo AIRA was built to change that – by MedTech professionals, for MedTech professionals.

Your team answers a guided questionnaire covering Intended Use, hazards, hazardous situations, and potential harms. AIRA's AI workflow automatically translates those answers into a complete risk analysis table – including Hazard → Hazardous Situation → Harm chain, P1/P2 logic, severity scoring, and risk evaluation.

The output is an Excel file ready to integrate into your Risk Management File and Design History File. After expert review and sign-off, it's ready for Notified Bodies and regulatory authorities.

Aligned with ISO 14971 and ISO/TR 24971.