Internal Research Source

Risk Register ISO 14971

ISO 14971-aligned risk register template covering hazards, harms, controls, verification evidence, and residual risk.

internal-csvEvidence status: active sourceUpdated 2026-02-15

How to read this source

Start with headings and summary blocks. Use this page to verify citations, claim wording, and chapter-level evidence support before interpreting conclusions.

Used by chapters

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SMS

In plain language: this template is a structured evidence table. Use it to map claims, thresholds, risks, and pass/fail criteria consistently.

risk_id	hazard	hazardous_situation	harm	severity	probability	initial_risk	control_measures	residual_risk	verification_method	owner	status
R-001	Low-light capture misread	User captures in dark scene; model outputs non-abstained result	Delayed clinical follow-up	High	Medium	High	Hard low-light QC gate; mandatory reacquire; abstain fallback	Low	QC unit tests + field simulation + audit log review	Safety Engineering	Open
R-002	Glare-driven feature corruption	Specular reflections on sclera/conjunctiva pass weak QC	False positive risk signal	Medium	Medium	Medium	Glare detector + ROI mask + multi-frame consistency checks	Low	Synthetic glare stress suite + prospective validation subset	Computer Vision	Open
R-003	Device pipeline shift	OS/camera update changes tone mapping	Performance drift	High	Medium	High	Device compatibility matrix; model monitoring; rollback controls	Medium	Post-market drift dashboard + release gate checklist	MLOps	Open
R-004	Demographic bias	Model underperforms in subgroup	Inequitable missed risk	High	Medium	High	Subgroup thresholds; fairness gate in release criteria; abstain tightening	Medium	Subgroup performance report in every model release	Clinical AI	Open
R-005	Unsafe wording	UI text implies definitive diagnosis	Inappropriate self-treatment	High	Low	Medium	Content lint checks; legal-approved claim library; UI copy tests	Low	Pre-release content audit + legal signoff	Product + Legal	Open
R-006	Insufficient incident handling	High-risk failure not escalated quickly	Patient safety impact	High	Low	Medium	Incident response SOP + on-call escalation + rollback trigger	Low	Tabletop incident drills + postmortem CAPA	Operations	Open