MedMI helps medical-device teams generate, review, trace, and export risk management documentation with AI assistance and RA/QA-controlled workflows.
Built for global medical device regulatory teams
Built for regulated medical-device documentation, avoiding generic AI outputs.
Generate your first RMF quickly for prototypes, design reviews, investor readiness, and regulatory planning without hiring expensive external consultants immediately.
Standardise risk management across multiple product lines and maintain controlled, exportable RMF records that stand up to notified body scrutiny.
Create client-ready RMF documents faster using structured outputs. Drastically reduce the time spent on blank spreadsheets and initial hazard brainstorming.
Maintain traceable risk documentation from design input to verification and post-market feedback. Export review-ready risk control documentation effortlessly.
A controlled, AI-assisted 5-step workflow.
Define your medical device scope, target users, and clinical environment.
Categorize the device for targeted ISO 14971, IEC 62304, or IEC 62366-1 analysis.
AI-assisted hazard identification creates a comprehensive baseline instantly.
Your QA team reviews, edits, and approves the generated risk control documentation.
Download audit-ready traceability matrices and risk management plans.
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.
MedMI does not replace your Quality Management System; it accelerates it. Our platform is designed around strict RA/QA principles.
Regulatory Disclaimer: MedMI assists in preparing structured risk management documentation. Final review, approval, and regulatory responsibility remain solely with the medical device manufacturer.
Everything you need to demonstrate compliance during an ISO 13485 or FDA inspection.
Structured, narrative risk management plans and reports.
Maintain snapshots of your RMF for iterative design reviews.
Built-in stages for authoring, reviewing, and approving risks.
Download formatted Excel traceability matrices instantly.
Customize probability and severity scales to your SOPs.
Directly addresses Annex C hazards and hazardous situations.
Ensures QA teams maintain ultimate regulatory sign-off.
Track who modified risk controls and when, for Part 11 readiness.
See exactly what our AI generates. Get a free sample Risk Management Plan, Risk Analysis Table, Evaluation Matrix, and Benefit-Risk Justification.
Yes. The structure, probability scales, severity matrices, and hazard groupings generated by MedMI are specifically aligned with ISO 14971:2019.
Absolutely. We provide full exports to Microsoft Excel to maintain your traceability matrices.
Yes. The output is structured to support preparation of structured documentation commonly expected in CE MDR technical files and FDA QMSR-aligned quality-system records, subject to manufacturer review and approval.
No. MedMI is an AI-assisted drafting tool. Final review and approval must be performed by your qualified human regulatory/QA personnel.
Yes. Your proprietary device profiles are securely stored and are never used to train public large language models.
