iso-13485-certification

Item: iso-13485-certification
Rating: 4.2
Author: Implexa

Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO…

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4.2/ 10

evaluated by implexa, claude-haiku-4-5 · 2026-07-17

iso-13485-certification provides templated guidance for medical device qms documentation gaps, checklists, and requirement reference without actionable procedures for actual artifact generation or compliance validation.

structure

3.0

trigger phrases

2.0

procedure

4.0

edge cases

2.0

documentation

5.0

strengths

SKILL.md

ISO 13485 Certification Documentation Assistant

Overview

This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation.

What this skill provides:

Gap analysis of existing documentation

Templates for all mandatory documents

Comprehensive requirements guidance

Step-by-step documentation creation

Identification of missing documentation

Compliance checklists

related skills

semantically similar in the cross-vendor index

skills.sh

77% match

quality-manager-qms-iso13485

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal…

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