iso14971-risk-analyzer
Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
npx skills add a5c-ai/babysitter --skill iso14971-risk-analyzer --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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 desig
- Purpose
- Capabilities
- Usage Guidelines
- When to Use
- Prerequisites
- Best Practices
- Process Integration
- Dependencies
- Configuration
- Output Artifacts
- Quality Criteria
What does the iso14971-risk-analyzer skill do?
Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
How do I install it?
Run `npx skills add a5c-ai/babysitter --skill iso14971-risk-analyzer --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From a5c-ai/babysitter, a repository with 1,642 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.