claude-skills

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use when planning internal audits, executing audits, classifying findings, preparing for external audits, or managing an audit program.

Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review.

Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use when working on document control procedures, change control workflows, document numbering, version management, electronic signature compliance, or regulatory documentation review.

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2. Use when leading management reviews, setting quality policy and objectives, monitoring quality KPIs and cost of quality, or exercising QMR governance and regulatory oversight responsibilities.

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

Use when the user asks to design a RAG pipeline, choose a chunking strategy or embedding model, pick a vector database, or evaluate retrieval quality (precision@k, recall@k, NDCG). Examples: 'design a RAG system for our docs', 'what chunk size should I use for this corpus', 'evaluate my retriever against ground truth'. NOT for general LLM cost tuning (use llm-cost-optimizer) or agent loops over retrieval (use agenthub).

Use when the user asks to design a RAG pipeline, choose a chunking strategy or embedding model, pick a vector database, or evaluate retrieval quality (precision@k, recall@k, NDCG). Examples: 'design a RAG system for our docs', 'what chunk size should I use for this corpus', 'evaluate my retriever against ground truth'. NOT for general LLM cost tuning (use llm-cost-optimizer) or agent loops over retrieval (use agenthub).

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').

Router/index for the 15 regulatory & quality-management skills bundled in this plugin (ISO 13485 QMS, EU MDR 2017/745, FDA submissions under QMSR, ISO 14971 risk, CAPA, document control, ISO 27001/ISMS, ISO 42001 AIMS, EU AI Act, GDPR/DSGVO, SOC 2, auditing). Use when a compliance request doesn't obviously match one skill and you need to pick the right one (e.g., 'prepare us for an ISO 13485 audit', 'is my AI system high-risk under the AI Act').

Turns a suspected bug into a proven one. Verify the cause against reality before claiming it, write a test that FAILS on the current code, apply the fix, watch it pass — then revert the fix and confirm the test goes red again, because a test that passes both ways proves nothing. Invoked bare after a debugging conversation, it takes the target from context rather than asking. Use when fixing a bug, investigating an incident, hardening a flaky area, or when asked to "add tests that reveal the bug". Triggers on "/red-green-proof", "prove the bug", "red-green", "make the test fail first", "is that test load-bearing", "reveal the bug with a test".

Turns a suspected bug into a proven one. Verify the cause against reality before claiming it, write a test that FAILS on the current code, apply the fix, watch it pass — then revert the fix and confirm the test goes red again, because a test that passes both ways proves nothing. Invoked bare after a debugging conversation, it takes the target from context rather than asking. Use when fixing a bug, investigating an incident, hardening a flaky area, or when asked to "add tests that reveal the bug". Triggers on "/red-green-proof", "prove the bug", "red-green", "make the test fail first", "is that test load-bearing", "reveal the bug with a test".

Use when planning or executing authorized red team engagements, attack path analysis, or offensive security simulations. Covers MITRE ATT&CK kill-chain planning, technique scoring, choke point identification, OPSEC risk assessment, and crown jewel targeting.

Use when planning or executing authorized red team engagements, attack path analysis, or offensive security simulations. Covers MITRE ATT&CK kill-chain planning, technique scoring, choke point identification, OPSEC risk assessment, and crown jewel targeting.

When the user wants to design, launch, or optimize a referral or affiliate program. Use when they mention 'referral program,' 'affiliate program,' 'word of mouth,' 'refer a friend,' 'incentive program,' 'customer referrals,' 'brand ambassador,' 'partner program,' 'referral link,' or 'growth through referrals.' Covers program mechanics, incentive design, and optimization — not just the idea of referrals but the actual system.

When the user wants to design, launch, or optimize a referral or affiliate program. Use when they mention 'referral program,' 'affiliate program,' 'word of mouth,' 'refer a friend,' 'incentive program,' 'customer referrals,' 'brand ambassador,' 'partner program,' 'referral link,' or 'growth through referrals.' Covers program mechanics, incentive design, and optimization — not just the idea of referrals but the actual system.

Mid-conversation reflection skill that pauses execution and zooms out from detail-mode to honestly reassess direction, assumptions, and bias. Use when the user says 'reflect', 'take a step back', 'step back', 'zoom out', 'are we missing something', 'bigger picture', 'sanity check this', 'are we on track', 'are we overthinking this', 'forest for the trees', or any variation signaling intent to break out of detail-mode and reassess. Also trigger when the conversation has gone deep on implementation details without strategic check-in, or when the user shows signs of being stuck — that's often a signal the framing needs a reset, not more detail work. Intentionally low-intake: runs the 5-dimension analysis immediately when prior context is rich enough; asks one forcing clarifier only when invocation context is too thin to reassess from.

Mid-conversation reflection skill that pauses execution and zooms out from detail-mode to honestly reassess direction, assumptions, and bias. Use when the user says 'reflect', 'take a step back', 'step back', 'zoom out', 'are we missing something', 'bigger picture', 'sanity check this', 'are we on track', 'are we overthinking this', 'forest for the trees', or any variation signaling intent to break out of detail-mode and reassess. Also trigger when the conversation has gone deep on implementation details without strategic check-in, or when the user shows signs of being stuck — that's often a signal the framing needs a reset, not more detail work. Intentionally low-intake: runs the 5-dimension analysis immediately when prior context is rich enough; asks one forcing clarifier only when invocation context is too thin to reassess from.