AQA Company, Inc. software

ISO 14971 Risk Management

IMSXpress - Medical Device Risk Management and Hazard Analysis Software

IMSXpress 14971 Medical Device Risk Management software is a Windows application for implementing Risk Analysis, Risk Evaluation, and Risk Control in strict compliance with the ISO 14971:2012 standard. Risk analysis, risk evaluation, and risk control methodologies strictly follow requirements of ISO 14971 and all recommendations included in ISO 14971 Annex B through E. Reports generated by IMSXpress comply with ISO 14971 requirements for Risk Management File (Clause 3.5) and provide most of the content required for that file.