rmForge™rmForge is web software that drafts an ISO 14971 Hazard Analysis for your medical device from your Instructions for Use and product requirements. From the finished Hazard Analysis, it can then draft a Design FMEA or a Process FMEA.
Sign up and book a working session with rmForge. We build your first ISO 14971:2019 Hazard Analysis together, traceable to your Product Requirements and User Needs. On payment, you receive the review-ready workbook.
AI models read your documents to draft the analysis, an outside service scans them for viruses, and we keep them until you ask us to delete them.
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Bare metal coronary stent, synthetic test device
| Risk ID | Hazard | Foreseeable Sequence of Events | Hazardous Situation | Harm | S | Po | Risk Level |
|---|---|---|---|---|---|---|---|
| HZ-0046 | Potential or stored energyCompressionNormalIntended Use |
| Patient coronary artery lumen progressively narrowed by neointimal tissue growth within the stented segment | Myocardial ischemia | 4 | 3 | High |
| HZ-0109 | DeliveryRateFaultMisuse: Use Error |
| Patient coronary artery wall subjected to asymmetric radial force during stent deployment | Coronary dissection | 4 | 2 | Medium |
| HZ-0072 | Biological agentsVirusesFaultIntended Use |
| Patient bloodstream exposed to viral agents on stent surface during coronary implantation | Viral infection | 4 | 1 | Medium |
| HZ-0064 | Chemical agents - pyrogenicPyrogenicFaultIntended Use |
| Patient bloodstream exposed to pyrogenic material on stent surface during coronary implantation | Fever | 2 | 2 | Low |
From a real rmForge Hazard Analysis on a synthetic test device. Draft output for qualified review.
After more than 20 years in medical device development, I’ve participated in dozens of hazard analyses, FMEAs, and risk management activities. rmForge is one of the most effective tools I’ve seen for improving both the speed and quality of these efforts.
We LOVE this tool!
Scores that hide severe harm, controls missing from the design, and stale files can leave a patient exposed.
A rare, severe harm can land in the same risk band as a frequent, minor one. If the band alone decides what gets controlled, the row that could seriously injure a patient can slip through.
rmForge reads Risk Level from fixed lookup tables, and any harm rated Severity 4 or 5 needs a Risk Control Measure whatever its Risk Level.
A risk control that never becomes a Product Requirement may be missing from the device. It cannot be verified, so the harm it targets can still reach the patient.
rmForge proposes each Risk Control Measure with its implementation and verification, for your team to review and complete.
A risk file can be closed at Design Transfer and never updated. As clinical practice and use change, new ways a patient can be hurt go unrecorded.
When you revise a Hazard Analysis, rmForge returns a redlined workbook with a Change Summary.
Nine things that drain a program, and what rmForge does about each one. Press a plaque to turn it and hold it.
The wave is showing what it costs your team. Press any plaque to turn it and hold it.
Three steps from first call to a review-ready Hazard Analysis. A Design or Process FMEA can then be drafted from it.
New to this? Read what a Hazard Analysis is for a medical device.
Sign up and schedule a working session with rmForge.
On a screen share, we run your device through the wizard and generate the Hazard Analysis, traceable to your Product Requirements and User Needs.
We review a drafted portion together and you decide on services and payment. On payment, you receive your ISO 14971:2019 Hazard Analysis workbook.
Fixed rules do the risk math and check every row, AI drafts the rows, and your team decides. See which part does what.
Sign up and book a working session. We build your first Hazard Analysis with you.
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