rmForge

AI-powered hazard analysis and risk management for medical devices

Step through the rmForge intake wizard. Upload your Design Inputs and Instructions for Use (IFU) for full traceability. rmForge produces a Hazard Analysis workbook aligned to ISO 14971:2019, ready for team review.

Your documents are processed securely and never shared or stored beyond your choice.

References:ISO 14971:2019IEC 62366-1FDA 510(k)CE MarkMDR 2017/745 Annex II

How it works

Three steps from your source documents to a regulatory-ready risk table.

01

Answer the Hazard Questionnaire

Walk through device characterization. Your selections drive the Hazard Identification Questionnaire and inform every downstream row.

02

rmForge traces hazards to your requirements

Hazards are mapped to your User Needs and Product Requirements with forward and backward traceability.

03

Download a review-ready Hazard Analysis

Completed Hazard Analysis per ISO 14971:2019, ready to drop into your Technical Documentation.

Start a Hazard Analysis

Sign up and the Hazard Analysis Wizard will guide through your first analysis.

Get started