validate-ai-device

validate-ai-device is a command for Claude Code from alexclowe/awesome-claude-cowork-plugins. It costs 24 tokens per session (801 once invoked), scanned A, original, MIT.

A review of the clinical validation evidence for an AI-enabled medical device. Clinical validation checks whether a device works as intended for its stated medical use and target population.

In plain words
What is it for?
Use it to review intended use, device classification, validation data, performance measures, submission route, design controls, and gaps against FDA quality and machine-learning guidance.
Why use it?
It helps identify missing evidence and documents that could delay an FDA submission or weaken confidence in the device's performance.

Command for Claude Code

Written for Claude Code: user-invocable in frontmatter.

Part of the healthcare-compliance-officer plugin — 2 skills, 4 commands shipped together

Good fit Use it to review intended use, device classification, validation data, performance measures, submission route, design controls, and gaps against FDA quality and machine-learning guidance.

Compare 6 commands from other repositories ↓
Install with agentmods
npx agentmods add commands/alexclowe/awesome-claude-cowork-plugins/validate-ai-device
Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Clone the repo
git clone --depth 1 https://github.com/alexclowe/awesome-claude-cowork-plugins

Made for: Claude Code.

Or install healthcare-compliance-officer, the plugin that ships this one along with the rest of its 2 skills, 4 commands.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for validate-ai-device

README.md
[![agentmods](https://agentmods.dev/badge/commands/alexclowe/awesome-claude-cowork-plugins/validate-ai-device/github.svg)](https://agentmods.dev/commands/alexclowe/awesome-claude-cowork-plugins/validate-ai-device)
Your own site
<a href="https://agentmods.dev/commands/alexclowe/awesome-claude-cowork-plugins/validate-ai-device"><img src="https://agentmods.dev/badge/commands/alexclowe/awesome-claude-cowork-plugins/validate-ai-device/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for validate-ai-device

Your own site · 80×15
<a href="https://agentmods.dev/commands/alexclowe/awesome-claude-cowork-plugins/validate-ai-device"><img src="https://agentmods.dev/badge/commands/alexclowe/awesome-claude-cowork-plugins/validate-ai-device.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 24 Only the description is in the session, so the agent can decide to use it. The body loads when it is invoked.
When invoked 801 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00024 $0.00801
Opus 5.5 $0.00010 $0.00320
Sonnet 5.5 $0.00005 $0.00160
Haiku 4.5 $0.00002 $0.00080

Measured 23d ago against content hash 1a4b8ae8d553, method: parsed. Prices are Anthropic first-party input rates as of 2026-10-07, from the pricing page.

Security

Grade A, and why

validate-ai-device scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 23d ago.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

healthcare-compliance-officer/commands/validate-ai-device.md · 71 lines

How it starts

The opening of the file, as written. The whole thing — 71 lines — stays where its author put it; the contents beside it link to each section on GitHub.

You are a healthcare compliance assistant helping a healthcare compliance officer assess the validation package for an AI-enabled medical device.

The user will describe a device — its intended use, technology, validation data, performance metrics, and target submission pathway. Your job is to:

  1. Map the device to FDA framework — device classification, intended use, indications for use, GMLP applicability, January 2026 post-market shift implications
  2. Audit the validation package against QSR (21 CFR 820), the AI/ML SaMD Action Plan, and FDA Good Machine Learning Practice (GMLP) principles
  3. Identify documentation gaps that would block or delay submission, organized by severity
  4. Recommend remediation with effort estimates and prerequisite dependencies

Output format

Structure your response as:

Device Profile (echo back)

  • Generic name / common name
  • Intended use / indications for use
  • Device classification: [Class I / II / III]
  • Submission pathway: [510(k) / De Novo / PMA / exempt]
  • Predicate or comparator: [if known]

Regulatory Framework Map

Requirement Source Applies Notes
Design controls 21 CFR 820.30 ... ...
Risk management ISO 14971 ... ...
Software lifecycle IEC 62304 ... ...
Usability engineering IEC 62366-1 ... ...
Clinical evaluation 21 CFR 860.7, FDA clinical decision support guidance ... ...
GMLP principles FDA GMLP guiding principles (2021, updated) ... ...
Post-market surveillance FDA Jan 2026 post-market guidance, 21 CFR 803, 21 CFR 822 ... ...
PCCP FDA PCCP final guidance (Dec 2024) ... ...

Validation Package Audit

For each domain (analytical validation, clinical validation, human factors, cybersecurity, real-world performance):

  • Status: Complete / Partial / Missing / Not applicable
  • Evidence reviewed: ...
  • Gap: ...
  • Severity: [Critical / Major / Minor]

Documentation Gap Report

Read the full file on GitHub · 71 lines

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 23d ago First seen · 71 lines · 24 tokens per session scan A 1a4b8ae8d553

Subscribe to this mod's changes

validate-ai-device is a command published in the GitHub repository alexclowe/awesome-claude-cowork-plugins (30 stars, last pushed 4d ago), licensed MIT. It adds 24 tokens to every session and 801 once invoked, about $0.0001 per session on Opus 5.5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-24.