Individual skill

risk-management-specialist

Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.

skills-imported/risk-management-specialist/SKILL.md

Read pinned source

Source commit faf37c0859ebf627bfcb5225e8057d088691e0ae

What was checked

Matches the observed repository HEAD: Yes
Scanner rules are current: Yes
Repository scan complete: No
Skill scan complete: No
Observed behavior: Local scripts
Last checked: Nov 11, 2026

These are observations at the recorded commit, not a guarantee of safety. Review the source before running it.

Install this skill

Choose an agent in your Stack or copy a command below. Commands fetch the pinned commit and copy only this skill directory. Existing destinations are refused. Copying a command does not install anything.

An install command is unavailable: current rules, complete repository and skill scans, an eligible behavior level and a permitted license are required.

Repository context

Repository stars (not skill ratings): 56
Repository last updated: Oct 10, 2026
License: MIT

Observed agent integration: No specific integration evidence. Standard SKILL.md installation does not imply verified compatibility.

agent-skills Repository topic
ai-agents Repository topic
ai-agents-automation Repository topic
ai-skills Repository topic
awesome Repository topic
awesome-list Repository topic
chatgpt Repository topic
claude-skills Repository topic
meta-ai Repository topic
muse-ai Repository topic
engineering Derived category

Files and excerpt

File metadata and permitted, redacted excerpts come from the recorded scan. Source links are pinned to that commit.

Browse files

SKILL.mdcore · 10,260 bytes
SKILL.mdcore · 10,260 bytes
assets/example_asset.txtdoc · 865 bytes
references/api_reference.mddoc · 977 bytes
scripts/example.pyruns · 611 bytes

Read excerpt


# Senior Risk Management Specialist

Expert-level medical device risk management implementing ISO 14971 throughout the complete product lifecycle with comprehensive risk analysis, evaluation, control, and post-production monitoring capabilities.

## Core Risk Management Competencies

### 1. Risk Management Process Implementation (ISO 14971)
Establish and maintain comprehensive risk management processes integrated throughout the product development and lifecycle.

**Risk Management Process Framework:**
```
ISO 14971 RISK MANAGEMENT PROCESS
├── Risk Management Planning
│   ├── Risk management plan development