Product Launch Legal Review
anthropics/claude-for-legal
Runs a category-by-category legal review of a product launch from a PRD or tracker ticket, calibrated to your team's framework, and writes a review memo in house format.
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle.
Install Risk Management Specialist
$ npx skills add borghei/Claude-Skills --skill risk-management-specialist -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install borghei/Claude-Skills risk-management-specialist --agent claude-codeProject scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/ra-qm-team/risk-management-specialist .claude/skills/risk-management-specialist && rm -rf skills-srcUse ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.
Claude Code skills documentation · loads skills from .claude/skills/
Install the "risk-management-specialist" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/risk-management-specialist into .claude/skills/risk-management-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "risk-management-specialist", then confirm the skill loads.Claude Code copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$skill-installer install https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/risk-management-specialistType this inside Codex. $skill-installer <name> installs a curated skill from openai/skills. The installer writes to $CODEX_HOME/skills (default ~/.codex/skills). Restart Codex if the skill does not show up.
$ npx skills add borghei/Claude-Skills --skill risk-management-specialist -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install borghei/Claude-Skills risk-management-specialist --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .agents/skills && cp -r skills-src/ra-qm-team/risk-management-specialist .agents/skills/risk-management-specialist && rm -rf skills-srcUse ~/.agents/skills/ instead of .agents/skills for a personal install.
Codex skills documentation · loads skills from .agents/skills/
Install the "risk-management-specialist" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/risk-management-specialist into .agents/skills/risk-management-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "risk-management-specialist", then confirm the skill loads.Codex copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add borghei/Claude-Skills --skill risk-management-specialist -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install borghei/Claude-Skills risk-management-specialist --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/ra-qm-team/risk-management-specialist .cursor/skills/risk-management-specialist && rm -rf skills-srcUse ~/.cursor/skills/ instead of .cursor/skills for a personal install.
Cursor skills documentation · loads skills from .cursor/skills/, .agents/skills/, .claude/skills/, .codex/skills/
Install the "risk-management-specialist" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/risk-management-specialist into .cursor/skills/risk-management-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "risk-management-specialist", then confirm the skill loads.Cursor copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gemini skills install https://github.com/borghei/Claude-Skills.git --path ra-qm-team/risk-management-specialist--scope user (default) or --scope workspace; --path is the subfolder of the repo that holds the skill; --consent skips the security confirmation prompt.
$ npx skills add borghei/Claude-Skills --skill risk-management-specialist -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install borghei/Claude-Skills risk-management-specialist --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/ra-qm-team/risk-management-specialist .gemini/skills/risk-management-specialist && rm -rf skills-srcUse ~/.gemini/skills/ instead of .gemini/skills for a personal install, then run /skills reload.
Gemini CLI skills documentation · loads skills from .gemini/skills/, .agents/skills/
Install the "risk-management-specialist" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/risk-management-specialist into .gemini/skills/risk-management-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "risk-management-specialist", then confirm the skill loads.Gemini CLI copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gh skill install borghei/Claude-Skills risk-management-specialistInstalls for Copilot at project scope by default; add --scope user for a personal install. Preview a skill first with gh skill preview. Needs GitHub CLI 2.90.0 or later (public preview).
$ npx skills add borghei/Claude-Skills --skill risk-management-specialist -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .github/skills && cp -r skills-src/ra-qm-team/risk-management-specialist .github/skills/risk-management-specialist && rm -rf skills-srcUse ~/.copilot/skills/ instead of .github/skills for a personal install. Commit .github/skills so cloud agent and code review can use it.
GitHub Copilot skills documentation · loads skills from .github/skills/, .claude/skills/, .agents/skills/
Install the "risk-management-specialist" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/risk-management-specialist into .github/skills/risk-management-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "risk-management-specialist", then confirm the skill loads.GitHub Copilot copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add borghei/Claude-Skills --skill risk-management-specialist -a opencodeOpenCode documents no install command of its own. Project install goes to .agents/skills/; add -g for ~/.config/opencode/skills/.
$ gh skill install borghei/Claude-Skills risk-management-specialist --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/borghei/Claude-Skills.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/ra-qm-team/risk-management-specialist .opencode/skills/risk-management-specialist && rm -rf skills-srcUse ~/.config/opencode/skills/ instead of .opencode/skills for a personal install.
OpenCode skills documentation · loads skills from .opencode/skills/, .claude/skills/, .agents/skills/
Install the "risk-management-specialist" agent skill from https://github.com/borghei/Claude-Skills/tree/main/ra-qm-team/risk-management-specialist into .opencode/skills/risk-management-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "risk-management-specialist", then confirm the skill loads.OpenCode copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
Facts
- Skill name
risk-management-specialist- GitHub stars
- 891
- Token cost
- ~1.9k tokens
- SKILL.md length
- 708 words
- Files
- 7 (incl. scripts, references)
- Skills in repo
- 354
- Repo updated
- First seen
- Licence
- MIT
At a glance
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle.
- Tasks that involve Legal risk assessment
- SKILL.md covers Core Capabilities, When to Use, Clarify First and Quick Start, plus 3 more sections
- Runs Python scripts from its folder; calls python
What it does
Risk Management Specialist is an agent skill from borghei/Claude-Skills. Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
Its SKILL.md is about 1.9k tokens, which your agent loads only when the skill is triggered. The skill folder holds 8 other files, including scripts and reference files (for example `references/extended-risk-domains.md`, `references/iso14971-implementation-guide.md` and `references/risk-analysis-methods.md`).
It sits in Legal & Compliance, covering Legal risk assessment. The repository describes itself as: 385 AI skills, 77 expert agents, and 900 stdlib Python tools for every team: engineering, PM, marketing, C-level, compliance, business ops, research, and a LinkedIn toolkit… The licence is MIT.
When your agent uses it
- Tasks that involve Legal risk assessment
Example prompts
- “/risk-management-specialist”
Requirements
- Python 3
What it can do on your machine
Read from SKILL.md and the folder at commit 4a698e8. It shows what the files ask for, not the result of running them.
Tool permissions
Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.
From allowed-tools in the SKILL.md frontmatter.
Runs code
Ships 1 file in scripts/ (Python), which the agent can run.
Shell commands in SKILL.md call:
python
From the folder's file list and the shell code blocks in SKILL.md.
Network
No URLs in SKILL.md.
From URLs in SKILL.md, links to its own repository left out.
Credentials
Names no API keys, tokens, secrets or passwords.
From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.
Context cost
Risk Management Specialist loads about 1.9k tokens when it runs, and up to ~18k if it reads all its reference files. Until then it costs about 55 tokens; SKILL.md has 708 words of instructions outside code blocks.
Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.
Safety
Auto-check passed
The automated check found no risky patterns in SKILL.md.
Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.
SKILL.md
The full file from borghei/Claude-Skills at commit 4a698e8, republished under its MIT licence (© borghei). 708 words, ~1,869 tokens.
Download SKILL.mdSave it as
.claude/skills/risk-management-specialist/SKILL.md (or your agent's skills folder). This skill also uses 6 other files; get the full folder from GitHub.- name
- risk-management-specialist
- description
- Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
- license
- MIT + Commons Clause
- metadata.version
- 1.1.0
- metadata.author
- borghei
- metadata.category
- compliance
- metadata.domain
- risk-management
- metadata.updated
- 2026-06-15
- metadata.tags
- iso-14971, risk-analysis, fmea, risk-register, medical-device
Risk Management Specialist
ISO 14971:2019 risk management implementation throughout the medical device lifecycle — planning, hazard analysis, risk evaluation, risk control, residual-risk assessment, and post-production monitoring — extended for AI/ML, cybersecurity (IEC 81001-5-1), supply chain, and cross-framework alignment (NIST CSF, DORA, NIS2).
Core Capabilities
- Risk management planning — scope, 5x5 acceptability matrix, RACI, verification and post-production planning
- Risk analysis & evaluation — hazard identification across 9 categories, P1-P5 / S1-S5 estimation, ALARP, benefit-risk triggers
- Risk control — priority hierarchy (inherent safety → protective measures → information for safety), verification methods, residual-risk evaluation
- Post-production monitoring — information sources, review triggers, RM-file update procedures, periodic review
- Extended domains — AI/ML risk (bias, drift, adversarial inputs), health-software cybersecurity, supply chain risk, cross-framework mapping
When to Use
- Implementing ISO 14971:2019 across the device lifecycle
- Building a hazard analysis / risk register using FMEA, FTA, HAZOP, or Use Error Analysis
- Evaluating residual risk and demonstrating ALARP or benefit-risk acceptability
- Extending risk management to AI/ML devices, cybersecurity, or supply chain
- Setting up post-production risk monitoring and Risk Management File update triggers
Clarify First
Before running the risk assessment, confirm these inputs. If any is unknown or vague, ASK — do not assume:
- Device and intended use — what it is and its use context (drives the hazard categories and benefit-risk analysis)
- Lifecycle stage — planning, hazard analysis, risk control, or post-production (picks the workflow)
- Acceptability criteria — the 5x5 matrix thresholds and ALARP definition (determines the risk-evaluation outcomes)
Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the risk register.
Quick Start
# ISO 14971 risk level (probability × severity, 1-5 each)
python scripts/risk_matrix_calculator.py --probability 3 --severity 4
# FMEA Risk Priority Number (severity / occurrence / detection, 1-10 each)
python scripts/risk_matrix_calculator.py --fmea --severity 8 --occurrence 4 --detection 3
# Guided interactive assessment, or list the full criteria scales
python scripts/risk_matrix_calculator.py --interactive
python scripts/risk_matrix_calculator.py --list-criteriaReferences
Load the reference that matches the task — keep this file lean and pull detail on demand:
- references/risk-process.md — full ISO 14971 process: planning, analysis, evaluation, control, and post-production workflows; 5x5 acceptability matrix; probability/severity criteria; hazard checklist; and the decision frameworks. Read when executing any lifecycle stage.
- references/risk-analysis-methods.md — FMEA, FTA, HAZOP, Use Error Analysis, and software hazard analysis methods. Read when choosing and applying a hazard-analysis technique.
- references/iso14971-implementation-guide.md — complete ISO 14971:2019 implementation framework with templates. Read for clause-level implementation detail.
- references/templates-and-tools.md — Hazard Analysis / FMEA worksheets, Risk Management Report template, full
risk_matrix_calculator.pyflag reference, troubleshooting table, and success criteria. Read when documenting assessments or diagnosing tool issues. - references/extended-risk-domains.md — AI/ML risk categories and methodology, IEC 81001-5-1 cybersecurity integration, supply chain risk, post-market monitoring automation, combined safety-security FMEA, and NIST CSF / DORA / NIS2 cross-framework mapping. Read for connected, software, or AI-enabled devices.
Show full SKILL.md (312 more words)Show less
Scope & Limitations
In Scope:
- ISO 14971:2019 risk management process implementation (planning, analysis, evaluation, control, residual risk, production/post-production)
- 5x5 risk matrix calculation and FMEA RPN scoring
- Hazard analysis methodology guidance (FMEA, FTA, HAZOP, Use Error Analysis, PHA)
- Risk control hierarchy application and verification planning
- Benefit-risk analysis framework
- Post-production risk monitoring and risk file update triggers
- AI/ML-specific risk management extensions (model bias, drift, adversarial inputs)
- Cybersecurity risk integration per IEC 81001-5-1
- Supply chain risk assessment methodology
- Cross-framework risk mapping (ISO 14971, NIST CSF, DORA, NIS2)
Out of Scope:
- Clinical investigation design or execution (risk management informs clinical strategy but does not execute studies)
- Software hazard analysis per IEC 62304 (the skill references software risk but detailed software lifecycle management requires IEC 62304 expertise)
- Biocompatibility testing or ISO 10993 evaluation (the skill identifies biological hazards but does not execute biocompatibility testing)
- Cybersecurity penetration testing or vulnerability scanning (use infrastructure-compliance-auditor for technical security testing)
- CAPA root cause analysis execution (use capa-officer for 5-Why, Fishbone, FTA, FMEA-based root cause investigation)
- Regulatory submission of risk management files (use regulatory-affairs-head for submission strategy and packaging)
Integration Points
| Skill | Integration |
|---|---|
| quality-manager-qms-iso13485 | Risk management (Clause 7.1) integrates with QMS product realization planning; risk file is part of the Design History File |
| capa-officer | Post-market risk signals may trigger CAPA; CAPA root cause analysis methods (FMEA, FTA) overlap with risk analysis techniques |
| regulatory-affairs-head | Risk management file is required for FDA submissions and EU MDR Technical Documentation; benefit-risk analysis supports clinical evaluation |
| quality-documentation-manager | Risk management file and records must be controlled per document control procedures (Clause 4.2) |
| fda-consultant-specialist | FDA cybersecurity guidance (2025 update) requires integration of security risks into ISO 14971 processes for premarket submissions |
| infrastructure-compliance-auditor | Technical security controls validated by the infrastructure auditor serve as risk mitigations for cybersecurity threats in the risk assessment |
| nist-csf-specialist | NIST CSF risk assessment (ID.RA) maps to ISO 14971 hazard identification and risk estimation; unified risk register possible |
© borghei, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file
Files
SKILL.md and 6 other files (scripts, references) in ra-qm-team/risk-management-specialist of borghei/Claude-Skills.
- SKILL.md
- references/extended-risk-domains.md
- references/iso14971-implementation-guide.md
- references/risk-analysis-methods.md
- references/risk-process.md
- references/templates-and-tools.md
- scripts/risk_matrix_calculator.py
Open the folder on GitHubat commit 4a698e8
Compare with similar skills
Risk Management Specialist next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.
| Skill | Stars | Used in | Tokens | Auto-check | Licence | Repo updated |
|---|---|---|---|---|---|---|
| Risk Management Specialist this skillborghei/Claude-Skills | 891 | — | ~1.9k | Automated safety check: Pass | MIT | |
| Product Launch Legal Reviewanthropics/claude-for-legal | 9.6k | 2 repos | ~5k | Automated safety check: Pass | Apache-2.0 | |
| Legal Risk Visualizationzh-xx/legal-assistant-skills | 174 | — | ~2.4k | Automated safety check: Pass | Apache-2.0 | |
| Contract Renewal Trackeranthropics/claude-for-legal | 9.6k | 2 repos | ~3.1k | Automated safety check: Pass | Apache-2.0 | |
| Deep Risk Analysiszubair-trabzada/ai-legal-claude | 1.8k | — | ~1.9k | Automated safety check: Pass | None | |
| Canghe Tianyanchafreestylefly/canghe-skills | 461 | — | ~2.4k | Automated safety check: Pass | None |
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Categories
Questions about Risk Management Specialist
What does Risk Management Specialist do?
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Risk Management Specialist is an agent skill from borghei/Claude-Skills. Medical device risk management specialist implementing ISO 14971 throughout product lifecycle.
When should I use Risk Management Specialist?
Risk Management Specialist fits situations like: tasks that involve Legal risk assessment.
How do I install Risk Management Specialist in Claude Code?
Run `npx skills add borghei/Claude-Skills --skill risk-management-specialist -a claude-code`. Or copy the skill folder (ra-qm-team/risk-management-specialist in borghei/Claude-Skills) into .claude/skills/risk-management-specialist in your project. Claude Code loads it when a task matches its description.
How do I install Risk Management Specialist in Codex?
Run `npx skills add borghei/Claude-Skills --skill risk-management-specialist -a codex`. Or copy the skill folder (ra-qm-team/risk-management-specialist in borghei/Claude-Skills) into .agents/skills/risk-management-specialist in your project. Codex loads it when a task matches its description.
Can I use Risk Management Specialist in Cursor, Gemini CLI or GitHub Copilot?
Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add borghei/Claude-Skills --skill risk-management-specialist -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/risk-management-specialist, .gemini/skills/risk-management-specialist, .github/skills/risk-management-specialist and .opencode/skills/risk-management-specialist in your project.
What does Risk Management Specialist need to run?
Going by SKILL.md and its folder, Risk Management Specialist needs Python for the scripts in its folder and the command-line tools its instructions call (python). Our summary lists: Python 3.
Does Risk Management Specialist access the network?
SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.
Is Risk Management Specialist safe to install?
Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.
What licence does Risk Management Specialist use?
Risk Management Specialist is published under the MIT licence (declared in SKILL.md). It allows redistribution, so the full SKILL.md is shown on this page.
How many tokens does Risk Management Specialist use?
About 1.9k tokens (SKILL.md is roughly 7.5k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 16k tokens, read only when the agent opens those files.
What are the alternatives to Risk Management Specialist?
Skills that share tags, products or a category with Risk Management Specialist: Product Launch Legal Review (anthropics/claude-for-legal, 9.6k stars), Legal Risk Visualization (zh-xx/legal-assistant-skills, 174 stars), Contract Renewal Tracker (anthropics/claude-for-legal, 9.6k stars) and Deep Risk Analysis (zubair-trabzada/ai-legal-claude, 1.8k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.
Who maintains Risk Management Specialist?
borghei (a GitHub user) maintains it in borghei/Claude-Skills, which has 891 GitHub stars. The repository holds 354 skills in this directory. The repository was last updated on October 7, 2026.
Source: borghei/Claude-Skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.