alterlab-iso13485
CommunityISO 13485 docs toolkit for medical devices.
AuthorAlterLab-IEU
Version1.0.0
Installs0
System Documentation
What problem does it solve?
ISO 13485:2016 compliance for medical devices requires a comprehensive, well-structured documentation system. This Skill provides a ready-to-use toolkit to streamline gap analysis, quality manual creation, and the development of the 31 documented procedures and Medical Device Files (MDFs), along with essential references and templates.
Core Features & Use Cases
- Gap analysis workflows that identify missing or non-compliant QMS elements against ISO 13485:2016.
- Templates and guidance for Quality Manual and key procedures (CAPA, Document Control, Records) and MDF structure.
- Step-by-step guidance to implement ISO 13485 alignment, including FDA QMSR transition considerations and regulatory crosswalk.
Quick Start
Run a gap analysis on your existing QMS documentation and draft your Quality Manual using the included templates.
Dependency Matrix
Required Modules
None requiredComponents
Standard package💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: alterlab-iso13485 Download link: https://github.com/AlterLab-IEU/AlterLab-Academic-Skills/archive/main.zip#alterlab-iso13485 Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
Agent Skills Search Helper
Install a tiny helper to your Agent, search and equip skill from 471,000+ vetted skills library on demand.