Solutions · Risk Management
ISO 14971,
without the
spreadsheet hell.
Hazard analysis seeded from your device’s MAUDE history. Risk-control traceability built automatically. Residual risk justification drafted with citations. A complete ISO 14971-conformant risk management file — not a template you fill in by hand.
Risk Intelligence Report
MAUDE · TPLC · Recalls
MDR Events
683
MAUDERecalls
7
FDATop risk signals
AI suggestion
289 resistance failures linked to tip material. Add Hazard H-07: Material fatigue under thermal cycling. ISO 14971 § 4.3 applies.
What Complizen produces
A complete risk management file, not a blank template.
Hazard identification & analysis
Hazard list seeded from your device type's MAUDE history — with severity, probability, and risk level pre-populated for review.
Risk-control traceability matrix
Each hazard linked to its risk control measures, verification method, and residual risk assessment — fully traceable per ISO 14971.
FMEA (Failure Mode and Effects Analysis)
Systematic failure mode analysis for your device subsystems, with cause, effect, severity, occurrence, and detectability scoring.
Residual risk justification
AI-drafted residual risk acceptability statements with citations to ISO 14971 and clinical benefit rationale based on your device type.
Risk Management Report
The final summary document required by ISO 14971 §10 — confirming overall residual risk is acceptable and the risk management process is complete.
Post-market surveillance links
Risk file structured for PMS integration — MDR triggers, trend thresholds, and MAUDE monitoring set up from day one.
“The risk file gave us one source of truth from hazard analysis through post-market — and let us move forward without wondering what we'd missed.”
Ángel Enríquez, Ph.D.
Founder & CEO, EmboaMed
Powered by
Standards conformance
- ISO 14971:2019 — Risk Management
- ISO/TR 24971:2020 — Guidance on ISO 14971
- IEC 62366-1 — Usability engineering