See how rmForge works
rmForge is a working session, not a self-serve form. You bring your device documents, we run the analysis with you on a screen share, and your review-ready ISO 14971:2019 Hazard Analysis workbook is delivered on payment.
Get startedHow a working session runs
Tell us about your device
Create an account and answer a short questionnaire: device, classification, stage, timeline. About two minutes.
Book your working session according to qualification
Pick a time on the rmForge calendar and we can run an analysis.
Run the analysis together
On a screen share, we walk your device through the rmForge questionnaire and generate hazard lines traceable to your Product Requirements and User Needs if provided.
Review a few lines together
We read a drafted portion together: hazards, hazardous situations, harms, severity, and probability. Risk levels come from fixed lookup tables, not model guesses.
Decide on Services and Payment: Leave with the workbook
On payment, you receive a Hazard Analysis workbook by email and in your dashboard. Outputs are draft and require qualified cross functional human review.
Watch a session
A recorded walkthrough is on the way. The sample below shows what the finished workbook looks like.
A sample of the finished work
Below is an excerpt from a completed Hazard Analysis for a bare metal coronary stent, a synthetic test device. The finished workbook carries 26 columns per row; seven are shown here.
| Risk ID | Hazard | Hazardous Situation | Harm | Severity | Po | Risk Level |
|---|---|---|---|---|---|---|
| HZ-0002 | Kinetic energyMechanical energy | Patient distal coronary vasculature occupied by a migrating metallic strut fragment | Coronary embolism | 5 | 2 | High |
| HZ-0003 | RateDelivery | Patient coronary artery wall subjected to asymmetric radial force during stent deployment | Coronary dissection | 4 | 2 | Medium |
| HZ-0005 | VirusesBiological agents | Patient bloodstream exposed to viral agents on stent surface during coronary implantation | Viral infection | 4 | 1 | Medium |
| HZ-0025 | PyrogenicChemical agents - pyrogenic | Patient bloodstream exposed to pyrogenic material on stent surface during coronary implantation | Fever | 2 | 2 | Low |
Illustrative excerpt from a real rmForge output: 4 rows and 7 of the workbook's 26 columns. Outputs are draft and require qualified human review before any regulatory submission.
- Every row carries a stable Risk ID, so reviews and revisions trace cleanly across document revisions.
- Each line is written for a reviewer: clear, consistently structured language and controlled vocabulary, ready for your quality system after cross functional review.
- Severity and probability map to a risk level through lookup tables defined in the risk management plan, applied the same way on every row.
Ready to see it on your device?
Sign up, answer a short questionnaire, and book a working session. We build your first Hazard Analysis with you.
Get startedQuestions first? Read the FAQ.