medical-device-software-compliance

medical-device-software-compliance is a skill for Claude Code, Codex from awslabs/hcls-agent-skills. It costs 296 tokens per session (5,359 once invoked), scanned A, original, MIT-0.

A reasoning skill for regulatory compliance of software that performs medical functions, including guidance for United States FDA and European Union medical-device submissions.

In plain words
What is it for?
Use it to consider IEC 62304 safety classes, ISO 14971 risk management, quality-system requirements, Design History Files, and 510(k), De Novo, or PMA pathways.
Why use it?
It helps organize safety, risk, quality, and submission decisions that medical-device software teams must document and justify.

Skill for Claude CodeCodex ✓ vendor

Which agent this was written for is unclear — body not stored (licence); the path alone says nothing.

Good fit Use it to consider IEC 62304 safety classes, ISO 14971 risk management, quality-system requirements, Design History Files, and 510(k), De Novo, or PMA pathways.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/awslabs/hcls-agent-skills/medical-device-software-compliance
About the project

awslabs/hcls-agent-skills is a collection of reusable instructions that help AI agents handle healthcare and life sciences work, including genomics, medical imaging, claims, and drug discovery. It is intended for agents running on Agent Skills-compatible platforms, and the catalogue entries are its individual domain skills.

awslabs/hcls-agent-skills · 33 stars · on GitHub

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.

Any agent
npx skills add awslabs/hcls-agent-skills --skill medical-device-software-compliance
Clone the repo
git clone --depth 1 https://github.com/awslabs/hcls-agent-skills

Made for: Claude Code, Codex.

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 medical-device-software-compliance

README.md
[![agentmods](https://agentmods.dev/badge/skills/awslabs/hcls-agent-skills/medical-device-software-compliance/github.svg)](https://agentmods.dev/skills/awslabs/hcls-agent-skills/medical-device-software-compliance)
Your own site
<a href="https://agentmods.dev/skills/awslabs/hcls-agent-skills/medical-device-software-compliance"><img src="https://agentmods.dev/badge/skills/awslabs/hcls-agent-skills/medical-device-software-compliance/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 medical-device-software-compliance

Your own site · 80×15
<a href="https://agentmods.dev/skills/awslabs/hcls-agent-skills/medical-device-software-compliance"><img src="https://agentmods.dev/badge/skills/awslabs/hcls-agent-skills/medical-device-software-compliance.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 296 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 5,359 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 unknown 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 $0.00296 $0.05359
Opus 5 $0.00148 $0.02679
Sonnet 5 $0.00059 $0.01072
Haiku 4.5 $0.00030 $0.00536

Measured 12d ago against content hash 87bfc0ff9d59, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-12, from the pricing page.

Security

Grade A, and why

medical-device-software-compliance 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 12d 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.

skills/medical-device-software-compliance/SKILL.md · 447 lines

The source is not reproduced here

Licensed MIT-0

The repository is licensed MIT-0, which this catalogue does not treat as permission to reproduce the file. Read it at the source.

Read it on GitHub

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. 12d ago First seen · 447 lines · 296 tokens per session scan A 87bfc0ff9d59

Subscribe to this mod's changes

medical-device-software-compliance is a skill published in the GitHub repository awslabs/hcls-agent-skills (33 stars, last pushed 11d ago), licensed MIT-0. It adds 296 tokens to every session and 5,359 once invoked, about $0.0015 per session on Opus 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 2026-08-30.

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