Solutions · Risk Management
ISO 14971,
without the
spreadsheet hell.
ISO 14971 is a connected system of hazard analysis, FMEA, traceability, residual risk, and post-market surveillance. Complizen guides you through each artifact: hazard lists seeded from MAUDE history, traceability built as you go, residual risk drafted with citations — so reviewers see a risk file that holds together.
Risk Intelligence Report
MAUDE · TPLC · Recalls
Top risk signals
289 resistance failures linked to tip material. Add Hazard H-07: Material fatigue under thermal cycling. ISO 14971 § 4.3 applies.
Across the risk management lifecycle
From hazard list to PMS, Complizen helps you build it — and keep it current.
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.
How it works
From hazard list to post-market — guided every step.
01Build your hazard list
Complizen seeds it from MAUDE history for your device type — severity, probability, and risk level pre-populated for your review.
02Add controls and traceability
Link each hazard to its control measure, verification method, and residual risk. The traceability matrix stays in sync as your design evolves.
03Justify residual risk
Complizen drafts acceptability statements with citations to ISO 14971 and clinical benefit rationale you can edit and defend.
04Connect to post-market
The risk file feeds PMS triggers, MDR thresholds, and MAUDE monitoring — so risk management continues after submission.
“It helped us build each piece, keep them connected, and defend the residual risk argument at every review.”
Ángel Enríquez, Ph.D.
Founder & CEO, EmboaMed
Conforms toISO 14971:2019ISO/TR 24971:2020IEC 62366-1
Run risk management
Risk management never stops. Neither does Complizen.
