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iso14971-risk-analyzer skill

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This skill helps medical device teams implement ISO 14971 risk analysis across hazard identification, risk estimation, control, and post-market monitoring.

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SKILL.md

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---
name: iso14971-risk-analyzer
description: Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
allowed-tools:
  - Read
  - Write
  - Glob
  - Grep
  - Edit
  - Bash
metadata:
  specialization: biomedical-engineering
  domain: science
  category: Risk Management
  skill-id: BME-SK-008
---

# ISO 14971 Risk Analyzer Skill

## Purpose

The ISO 14971 Risk Analyzer Skill implements comprehensive risk management methodology per ISO 14971:2019 for medical devices, supporting hazard identification, risk estimation, risk control, and benefit-risk analysis throughout the device lifecycle.

## Capabilities

- Hazard identification questionnaire generation
- Hazardous situation analysis templates
- Risk estimation matrix configuration
- Risk acceptability criteria setup
- Risk control measure tracking
- Residual risk evaluation
- Benefit-risk analysis documentation
- Risk management plan templates
- Risk management report generation
- Post-production risk monitoring
- Risk control verification tracking

## Usage Guidelines

### When to Use
- Establishing risk management plans
- Conducting hazard analyses
- Evaluating risk acceptability
- Documenting benefit-risk determinations

### Prerequisites
- Device intended use defined
- Reasonably foreseeable misuse identified
- Risk acceptability criteria established
- State of the art research completed

### Best Practices
- Begin risk management at concept phase
- Maintain risk management file throughout lifecycle
- Review risks at each design phase gate
- Integrate with post-market surveillance

## Process Integration

This skill integrates with the following processes:
- Medical Device Risk Management (ISO 14971)
- Human Factors Engineering and Usability
- 510(k) Premarket Submission Preparation
- EU MDR Technical Documentation

## Dependencies

- ISO 14971:2019 standard
- Risk matrix templates
- Hazard databases
- Safety standards (IEC 60601, IEC 62366)
- Post-market data sources

## Configuration

```yaml
iso14971-risk-analyzer:
  risk-categories:
    - clinical
    - electrical
    - mechanical
    - software
    - biocompatibility
    - sterility
    - usability
  probability-levels: 5
  severity-levels: 5
  acceptability-criteria:
    ALARP: true
    state-of-art: true
```

## Output Artifacts

- Risk management plans
- Hazard analysis worksheets
- Risk estimation matrices
- Risk control documents
- Residual risk evaluations
- Benefit-risk analyses
- Risk management reports
- Risk control verification records

## Quality Criteria

- All reasonably foreseeable hazards identified
- Risk estimation is systematic and documented
- Risk control measures are verified effective
- Residual risks are acceptable per criteria
- Benefit-risk analysis supports intended use
- Documentation meets ISO 14971:2019 requirements

Overview

This skill implements ISO 14971:2019 risk management methodology for medical devices to support hazard identification, risk estimation, risk control, and benefit-risk analysis throughout the device lifecycle. It produces structured artifacts like risk management plans, hazard worksheets, risk matrices, and residual risk evaluations to help teams meet regulatory quality criteria.

How this skill works

The skill generates targeted hazard identification questionnaires and hazardous situation templates, configures probability and severity matrices, and applies acceptability criteria such as ALARP and state-of-the-art. It tracks risk control measures, verifies their effectiveness, and compiles benefit-risk determinations and post-production monitoring outputs into documented reports suitable for technical files and submissions.

When to use it

At concept and design start to establish a risk management plan
During hazard analysis and preliminary risk estimation activities
When defining or validating risk acceptability criteria and matrices
To track implementation and verification of risk control measures
For compiling residual risk evaluations and benefit-risk documentation before submission

Best practices

Begin risk management at the concept phase and update continuously
Define intended use and reasonably foreseeable misuse before analysis
Use consistent probability and severity scales and document rationale
Integrate risk outputs with human factors, usability, and post-market surveillance
Maintain a living risk management file and verify controls prior to closure

Example use cases

Generating a hazard questionnaire for a new software-driven infusion pump
Configuring a 5x5 risk matrix and acceptability rules for a diagnostic device
Tracking mitigation tasks and verification evidence across design gates
Creating residual risk and benefit-risk analysis for a regulatory submission
Compiling post-production surveillance findings into updated risk reports

FAQ

Does the skill enforce a specific matrix size?

No, the skill supports configurable probability and severity levels (commonly 3–5) so you can align the matrix size with your organizational practice.

Can outputs be used for regulatory submissions?

Yes. Outputs are structured to support ISO 14971:2019 documentation needs and can be adapted into technical files or submission packages, but final review by the regulatory team is required.