ISO 14971 Medical Device Risk Management and Hazard Analysis
Available from AQA Co.
ISOXpress 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 14971:2007 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 ISOXpress comply with ISO 14971 requirements for Risk Management File (Clause 3.5) and provide most of the content required for that file.