mcpbeat Sign in

Iso 13485 Certification Agent Skill

Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

6k tokens
context cost
SKILL.md, read when the skill is used
9
files
ships runnable scripts
3
copies elsewhere
how many repositories repackaged it
73
stars on the repo
on the repository, not the skill itself

Install

one command, takes just this skill from the repository
npx skills add https://github.com/christophacham/agent-skills-library --skill iso-13485-certification

Other skills for the same job

different authors, same section of the catalogue
Executing Plans
by ZhanlinCui
×5

Use when you have a written implementation plan to execute in a separate session with review checkpoints

542 tokens
Tailored Resume Generator
by frostant
×4

Analyzes job descriptions and generates tailored resumes that highlight relevant experience, skills, and achievements to maximize interview chances

3.1k tokens
Excalidraw Diagram Generator
by github
vendor ×3

Generate Excalidraw diagrams from natural language descriptions. Use when asked to "create a diagram", "make a flowchart", "visualize a process", "draw a system architecture", "create a mind map", or "generate an Excalidraw file". Supports flowcharts, relationship diagrams, mind maps, and system architecture diagrams. Outputs .excalidraw JSON files that can be opened directly in Excalidraw.

5.9k tokens scripts
Expo Dev Client
by openai
vendor ×3

Build and distribute Expo development clients locally or via TestFlight

878 tokens
Labarchive Integration
by ComeOnOliver
×3

Electronic lab notebook API integration. Access notebooks, manage entries/attachments, backup notebooks, integrate with Protocols.io/Jupyter/REDCap, for programmatic ELN workflows.

2.3k tokens scripts
Molfeat
by ComeOnOliver
×3

Molecular featurization for ML (100+ featurizers). ECFP, MACCS, descriptors, pretrained models (ChemBERTa), convert SMILES to features, for QSAR and molecular ML.

3.7k tokens
Opentrons Integration
by ComeOnOliver
×3

Lab automation platform for Flex/OT-2 robots. Write Protocol API v2 protocols, liquid handling, hardware modules (heater-shaker, thermocycler), labware management, for automated pipetting workflows.

3.6k tokens scripts
Add Educational Comments
by github
vendor ×2

Add educational comments to the file specified, or prompt asking for file to comment if one is not provided.

1.6k tokens

How to use it

Copy the folder

Take christophacham/iso-13485-certification from the repository into ~/.claude/skills for personal use, or into .claude/skills inside a project.

Check the name does not clash

The agent identifies a skill by the name field in its header. Two skills with the same name cannot sit side by side — one of them will be ignored.