AlterLab ISO 13485
Skill ActivePart of the AlterLab Academic Skills suite. 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.
To assist medical device manufacturers in preparing and understanding the documentation required for ISO 13485 certification, streamlining the compliance process.
Features
- Automated gap analysis for ISO 13485 documentation
- Templates for Quality Manual, CAPA procedures, and more
- Detailed reference guides for ISO 13485 clauses and documents
- Guidance on common scenarios and best practices
- Script for analyzing existing documentation
Use Cases
- Starting the ISO 13485 certification process from scratch
- Conducting a gap analysis of existing QMS documentation
- Creating essential QMS documents like the Quality Manual and CAPA procedure
- Understanding specific ISO 13485 requirements and regulatory frameworks
- Preparing for a certification audit
Non-Goals
- Providing legal advice on specific regulatory interpretations
- Acting as a replacement for formal QMS consulting services
- Performing actual document audits or certifications
- Automating the entire QMS implementation process without user input
Practices
- Documentation Management
- Quality Management
- Regulatory Compliance
Trust
- warning:Issues Attention2 issues were opened in the last 90 days and are currently open, with 0 closed, indicating a potentially slow response rate from maintainers.
Installation
npx skills add AlterLab-IEU/AlterLab-Academic-SkillsRuns the Vercel skills CLI (skills.sh) via npx — needs Node.js locally and at least one installed skills-compatible agent (Claude Code, Cursor, Codex, …). Assumes the repo follows the agentskills.io format.
Quality Score
Trust Signals
Similar Extensions
TradeMemory Protocol
100Domain knowledge for the Evolution Engine — LLM-powered autonomous strategy discovery from raw OHLCV data. Covers the generate-backtest-select-evolve loop, vectorized backtesting, out-of-sample validation, and strategy graduation. Use when discovering trading patterns, running backtests, evolving strategies, or reviewing evolution logs. Triggers on "evolve", "discover patterns", "backtest", "evolution", "strategy generation", "candidate strategy".
Gdpr Dsgvo Expert
100GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
Prepare Inspection Readiness
100Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter and 483 theme analysis, mock inspection protocols, document bundle preparation, inspection logistics, and response template creation. Use when a regulatory inspection has been announced or is anticipated, when a periodic self-assessment is due, when new systems have been implemented since the last inspection, or after a significant audit finding that may attract regulatory attention.
Master Claude for Legal
100Master skill for legal teams using Claude. Loads the right reference for the user's question (privilege configuration, MCP hardening, verification, long documents, practice-area patterns, skill authoring) and routes to specialized starter skills (NDA triage, version diff, meeting brief, citation verification, status synthesis). Auto-invokes when the user mentions legal work, contracts, redlines, NDAs, privilege, attorney-client, court filings, depositions, regulatory compliance, or asks how to set up Claude for a law firm or in-house legal team.
ISO 13485 Certification Documentation Assistant
99Comprehensive 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.
Quality Documentation Manager
98Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.