Skills iso-13485-certification

📦

iso-13485-certification

Name: iso-13485-certification
Author: K-Dense-AI

Content revision r1 Safe 🔑 Env variables📁 Filesystem access⚙️ External commands

Prepare ISO 13485 Certification Docs

Medical device teams must create complete QMS documentation before certification audits. This skill provides templates, checklists, and gap analysis guidance for ISO 13485 readiness.

Supports: Claude Codex Code(CC)

🥇 85 Gold

Install with my Agent

Copy this request to your Agent. It includes the canonical Skill page and manifest.

Agent request

Review the Skillstore skill "iso-13485-certification" from https://skillstore.io/skills/k-dense-ai-iso-13485-certification.md and its manifest at https://skillstore.io/api/skills/k-dense-ai-iso-13485-certification/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.

Your Agent should still show its plan and request any confirmation required by the security policy.

Agent-readable resources

Use these links when an AI agent, crawler, or script needs clean context instead of reading the full page.

Markdown detail GET /skills/k-dense-ai-iso-13485-certification.md Signed manifest GET /api/skills/k-dense-ai-iso-13485-certification/manifest Signed lockfile GET /api/skills/k-dense-ai-iso-13485-certification/lockfile

Test it

Using "iso-13485-certification". We have a quality manual and CAPA procedure. What should we check next?

Expected outcome:

The skill would list likely missing core procedures, highlight document control and records control, and recommend a clause-based gap review.

Using "iso-13485-certification". Create a CAPA procedure for a Class II device manufacturer.

Expected outcome:

The skill would produce a structured procedure with purpose, scope, roles, CAPA initiation, investigation, action planning, verification, records, and approvals.

Using "iso-13485-certification". Help us prepare for an ISO 13485 audit in three months.

Expected outcome:

The skill would create a readiness plan covering document approval, training records, internal audit evidence, management review, CAPA status, and mock audit actions.

Security Audit

Safe

v9 • 7/9/2026 Open versioned report

Manual review found the static alerts are false positives caused by ISO 13485 terminology, markdown file references, and an explicit local report writer. No prompt injection, hidden network access, credential access, or unauthorized command execution was found in the reviewed files.

Files scanned

5,141

Lines analyzed

Review items

False positives ignored

Risk Factors

🔑 Env variables (69)

📁 Filesystem access (1)

scripts/gap_analyzer.py:402

⚙️ External commands (26)

No confirmed security findings were detected by the latest completed static and semantic audit. This does not prove the skill has no side effects.

Audited by: codex View Audit History →

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Open versioned report

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https://skillstore.io/skills/k-dense-ai-iso-13485-certification/audits/9?utm_source=security_passport&utm_medium=share&utm_campaign=versioned_report

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Academic citations (APA · BibTeX · CFF)

APA citation

K-Dense-AI. (2026). iso-13485-certification security audit report (audit version 9) [Author version unspecified]. Skillstore. https://skillstore.io/skills/k-dense-ai-iso-13485-certification/audits/9

BibTeX citation

@techreport{k-dense-ai-k-dense-ai-iso-13485-certification-2026,
  author = {K-Dense-AI},
  title = {iso-13485-certification security audit report (audit version 9)},
  institution = {Skillstore},
  year = {2026},
  number = {9},
  url = {https://skillstore.io/skills/k-dense-ai-iso-13485-certification/audits/9},
  note = {Author version unspecified}
}

CITATION.cff

cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "iso-13485-certification security audit report (audit version 9)"
version: "unspecified"
type: report
authors:
  - name: "K-Dense-AI"
date-released: "2026-07-09"
url: "https://skillstore.io/skills/k-dense-ai-iso-13485-certification/audits/9"
identifiers:
  - type: other
    value: "skillstore:k-dense-ai-iso-13485-certification:audit:9"
    description: "Skillstore immutable audit report identifier"

Skillstore Score

Why this score Evidence Confidence: High

Architecture

Maintainability

Content

Community

Spec Compliance

What You Can Build

Start a New QMS

Build the first set of ISO 13485 documents using a phased documentation roadmap.

Check Existing Documentation

Compare current procedures and manuals against ISO 13485 requirements before an audit.

Update Regulatory Alignment

Revise QMS documents for FDA QMSR, EU MDR, and ISO 13485 terminology consistency.

Try These Prompts

Explain Requirements

Explain the ISO 13485 documentation requirements for a small medical device company. Focus on the first documents we should create.

Review Current Documents

Analyze the QMS documents in my provided folder and summarize which ISO 13485 procedures and key documents appear missing.

Draft a Procedure

Help me draft a CAPA procedure for our organization. Ask for the missing company-specific details before producing the procedure.

Prepare Audit Readiness Plan

Create an ISO 13485 certification audit readiness plan using our gap report, document status, known exclusions, and target audit date.

Best Practices

Provide current procedures, product scope, device classes, and applicable regions before requesting document drafts.
Review every generated procedure with quality leadership before release or training.
Use the templates as controlled drafts and replace all placeholders with real process details.

Avoid

Do not copy template text into the QMS without matching actual company practices.
Do not treat the gap analyzer as proof of certification readiness.
Do not omit exclusion justifications from the Quality Manual.

Frequently Asked Questions

Can this skill certify my company to ISO 13485?

No. It helps prepare documentation, but certification requires an accredited audit and implemented QMS processes.

Does it include document templates?

Yes. It includes templates for a Quality Manual, CAPA procedure, and document control procedure.

Can it analyze my existing QMS documents?

Yes. The included script can scan a local document folder and identify likely documentation gaps.

Does it support FDA QMSR alignment?

Yes. The guidance discusses QMSR harmonization and Medical Device File updates.

Will it read PDF and office documents fully?

Not fully. The gap analyzer records some file types by filename, while text and markdown files get content scanning.

Should a regulatory expert review the outputs?

Yes. A qualified quality or regulatory professional should approve documents before controlled release.

Developer Details

Author

K-Dense-AI

License

MIT license

Skillstore revision

Version notice

The author did not declare a version.

Repository

https://github.com/K-Dense-AI/claude-scientific-skills/tree/main/scientific-skills/iso-13485-certification

Ref

26421118b848d9f1efc0aa169d8a7a9e7e0a877e

Maintenance freshness

7/18/2026

Usage

15 downloads · 241 views

File structure

📁 assets/

📁 templates/

📁 procedures/

📄 CAPA-procedure-template.md

📄 document-control-procedure-template.md

📄 quality-manual-template.md

📁 references/

📄 gap-analysis-checklist.md

📄 iso-13485-requirements.md

📄 mandatory-documents.md

📄 quality-manual-guide.md

📁 scripts/

📄 gap_analyzer.py

📄 SKILL.md

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iso-13485-certification

Install with my Agent

Agent-readable resources

Test it

Security Audit

Risk Factors

Copy report link

Markdown badge

HTML badge

Embed card

APA citation

BibTeX citation

CITATION.cff

Skillstore Score

What You Can Build

Start a New QMS

Check Existing Documentation

Update Regulatory Alignment

Try These Prompts

Best Practices

Avoid

Frequently Asked Questions

Developer Details

More from K-Dense-AI

venue-templates

pytdc

diffdock

hypothesis-generation

statistical-analysis

scanpy

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