ISO 14971 Risk File Author

Medical Devices ISO 14971 Risk Management Compliance Benefit-Risk

Overview

Guided elaboration of risk management file for medical devices per ISO 14971: hazard identification, risk analysis, risk control, residual risk acceptability, and benefit–risk rationale. Flags risks above acceptability thresholds without control or justification.

Getting Started

Add your source materials to the project workspace, then activate the ISO 14971 Risk File Author skill. The agent will guide you through the process step by step.

Example Conversation

You: Our risk analysis has several risks we’ve marked as “high” or “unacceptable”. I need to make sure each has either risk control or a benefit–risk justification in the risk management report.
Agent: I’ll run check_risk_acceptance_criteria on your risk file to find any high/unacceptable risk mentions that don’t have clear risk control or benefit–risk rationale nearby. Then we can add the missing controls or rationale.
Agent: The tool found three places where “high” or “unacceptable” risk is mentioned. One has a risk control and residual risk note; the other two don’t yet reference control measures or benefit–risk. I’ve added a “Risk control” and “Benefit–risk (if residual above criteria)” column to your risk table and drafted benefit–risk rationale for the two remaining items, referencing clinical benefit and acceptable residual risk per risk management plan.
You: Keep the rationale; we’ll get approval from the project lead.
Agent: The rationale is in place. Re-run check_risk_acceptance_criteria after any further risk updates to ensure no high/unacceptable risk is left without control or justification.

Sample Output Excerpt

Excerpt from a risk management file: risk evaluation and benefit–risk.

Risk evaluation (excerpt)

Hazard	Severity	Probability	Risk level	Risk control	Residual risk	Benefit–risk (if above criteria)
Electrical shock (user)	4	2	High	Double insulation; PE connection; user IFU	Low	N/A (residual acceptable)
Incorrect dose (software)	4	3	Unacceptable	Limits; confirmation step; alarm	Medium	Clinical benefit (therapy) outweighs residual risk; documented in RMR.
Latex allergy	3	2	Medium	Material change to non-latex	Low	N/A

Risk management report (RMR) documents benefit–risk determination for all residual risks above acceptability criteria per ISO 14971.

Built-in Validation Tools

The skill includes an extension tool that scans risk management documents for acceptability and benefit–risk coverage.

What the tool checks

Check	`check_risk_acceptance_criteria`
High/unacceptable risk	Looks for “high risk”, “unacceptable”, “above threshold”, severity/probability 4/5
Risk control / justification	Looks for risk control, control measure, mitigation, benefit–risk, benefit outweigh, rationale, residual risk acceptable
Findings	WARNING if high/unacceptable risk is present but control or benefit–risk justification is not; INFO when both are present
Scope	Focuses on risk analysis / evaluation / residual risk sections

Example validation output

======================================================================
ISO 14971 RISK ACCEPTANCE & BENEFIT–RISK CHECK
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Document: risk-management/risk-analysis.md

--- FINDINGS ---
  [WARNING] Document mentions high or unacceptable risk but does not clearly reference risk control measures or benefit–risk justification. Per ISO 14971, risks above acceptability criteria require risk control and/or documented benefit–risk rationale.
  [INFO] High/unacceptable risk and control or benefit–risk content found; verify every such risk has explicit control or benefit–risk rationale in the risk management report.

--- SUMMARY ---
  Errors: 0
  Warnings: 1
======================================================================

Run the tool on your risk management file or risk analysis document after updates; address warnings before design freeze or submission.