quality-manager-qms-iso13485

ISO 13485 Quality Management System specialist for medical device companies.

What this skill does for you

ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.

Quoted from the skill description in the pinned source

Who made it

Publisherdavila7

Repositoryclaude-code-templates

Installs316as of Sep 27, 2026

Use it with Edge

Set up Edge for me: read getedge.cc/SKILL.md and follow it. Then use Edge to load the quality-manager-qms-iso13485 skill from davila7/claude-code-templates.

Paste it into Claude, ChatGPT, Codex or Cursor.

Or read the skill source first.

Security evidence

Security state at 2026-09-30: reviewed. State definitions. This records static evidence for this revision; live load eligibility is checked again.

3 static scans, 0 counted findings. The listed scanners recorded the results shown for this package revision.

Scanner	Date	Result
Edge static checks	2026-09-27	Pass
Cisco skill-scanner	2026-09-27	Pass
Semgrep Edge rules	2026-09-27	Pass

Static scans check the code, not how well the skill works.

Scanner scope, raw findings and mirrored provider records

Edge static checks (Edge-run): edge-static/1.0.1. Scope: Static patterns for remote execution, credentials with network sends, obfuscation, prompt overrides, hidden Unicode, binaries and persistence. Revision: 6af7cdf57b810aca5e544a0f695bf058f1c2a744. Raw findings: . Counted findings: .

Cisco skill-scanner (Edge-run): cisco-skill-scanner/2.1.0. Scope: Local static, YARA, pipeline and behavioral analyzers; no LLM or AI Defense analysis. Revision: 6af7cdf57b810aca5e544a0f695bf058f1c2a744. Raw findings: 2. Counted findings: .

Semgrep Edge rules (Edge-run): semgrep/1.178.0+edge-rules.c15016a36fd3+offline-v1. Scope: Six Edge-authored static rules with Semgrep CE; offline execution and metrics disabled. Semgrep-maintained rules excluded. Revision: 6af7cdf57b810aca5e544a0f695bf058f1c2a744. Raw findings: . Counted findings: .

Source and licence

Repository: https://github.com/davila7/claude-code-templates
Pinned skill file: View source at revision
Revision: 6af7cdf57b810aca5e544a0f695bf058f1c2a744
Package hash: sha256:ce11b50cc57423cfb3fd4b929caa40be43f0cb92d457083ba5ae14b973f020fd
Licence: MIT