MedMI helps medical device startups and regulatory consultants generate editable hazards, risk controls, residual risk evaluations, and structured RMF documentation using guided ISO 14971-aligned workflows.
No credit card required · One guided RMF project · One Word export included
Supports preparation of documentation for global markets
MedMI converts your clinical device parameters into formal, reviewable risk records in 5 steps.
Enter intended use, users, patient population, operating environment, and basic device characteristics.
Select Active Device, SaMD, IVD, Neonatal, Electrical Equipment, or another pre-configured template.
Generate hazards, sequences of events, hazardous situations, clinical harms, and suggested risk controls.
Review all AI-generated content in a unified risk register, and configure your 5x5 acceptability matrix.
Export clean, audit-ready compliance tables directly to editable Word, Excel, or formatted PDF files.
See the actual workspace medical device companies use to maintain active documentation.
Specify indications, operator skills, and environmental characteristics to frame hazard assessment.
Leverage pre-loaded templates for Active Device, SaMD, IVD, Neonatal, or Electrical Medical Equipment.
Generate device-specific, structured hazards to jumpstart brainstorming sessions instantly.
Trace sequence of events, hazardous situations, and initial severity/probability scores.
Map controls to the mitigation hierarchy (design safety, protective measures, safety information).
Verify initial vs. residual risks on HSL color-coded 5x5 acceptability grids.
Watch our walkthrough demo video to see how to instantly generate a complete ISO 14971 Risk Management File, customize your risk matrix, and sign off with regulatory compliance.
Why leading medical startups choose structured risk databases over loose Excel files.
| Approach Parameters | Manual Excel Approach | MedMI Platform |
|---|---|---|
| Initial Baselines | Blank spreadsheets, copy-pasting from old logs | Guided device intake profiles |
| Hazard Discovery | Manual search through ISO standards and annexes | AI-assisted draft hazards compiled instantly |
| Document Setup | Repeated layout formatting, fixing cell heights | Structured template export layouts |
| Traceability Map | Separate risk analysis, plans, and reports | Connected database risk records |
| Acceptability Grid | Manual residual risk calculation on cells | Configurable risk matrix with auto-updates |
| Post-Market Loops | Difficult, slow updates that drift from records | Direct PMS-to-RMF linkage |
| Consultancy Operations | Repetitive effort starting fresh for each client | Reusable agency templates and workspaces |
Boost your consultancy's delivery speed. Save pre-configured risk profiles as reusable templates, isolate deliverables in secure client workspaces, and export white-labeled Excel, Word, or PDF logs.
Share a non-confidential description of your medical device. The MedMI team will help you prepare and review your first structured RMF draft.
₹15,000
₹35,000
₹60,000–₹75,000
Not a generic AI platform. Formulated around compliance expectations and international standards.
Directly addresses Annex C hazards, probability matrices, and clinical harms.
Active, passive, software, usable, neonatal, and electrical baselines.
AI acts as a draft co-author. Final modification remains in your full edit control.
Format-ready compliance artifacts ready to drop directly into your eQMS.
System explicitly requires human QA sign-off, protecting audit compliance.
Maintain living RMF files by feeding post-market complaints back into records.
Integrate software safety classes and user error tasks directly with hazards.
Customer content is not used by MedMI to train public models.
See how MedMI maps risk controls for active hardware, medical software, and critical care devices.
Electrical, battery-backup, and fluid-leakage hazard profiles.
Algorithmic anomalies, interface errors, and cybersecurity logs.
Pediatric dosing safety, thermal skin hazards, and critical sensor failures.
Generate hazards, risk controls, residual risk evaluations, and structured RMF documentation using an ISO 14971-aligned workflow.
No credit card required · One guided project · One Word export included
