Reusable expertise for your agents
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Curated directory
Featured Agent Skills
Ranked by source completeness, transparent community-adoption estimates, real Skill-level Dokki installs, and repository diversity.
- legal
iso13485-audit-prep
/cs:iso13485-audit-prep <scope> — ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused. Use before Clause 8.2.4 internal audit, MDR / FDA QSR alignment review, or product-launch DHF closure audit.
3k est. installs25k stars - legal
iso27001-audit-prep
/cs:iso27001-audit-prep <scope> — ISO 27001 ISMS audit readiness 6-question forcing interrogation. Use before annual Clause 9.2 internal audit, surveillance audit prep, or stage 1 certification readiness.
3k est. installs25k stars - legal
iso42001-specialist
ISO/IEC 42001:2023 AI Management System (AIMS) specialist for compliance teams running internal audits. Three decisions: (1) Where are the gaps against Clauses 4-10 and what do we close first? (2) What goes in the AI risk register and which Annex A controls treat each risk? (3) What's the 12-month internal audit plan that satisfies Clause 9.2? Use when preparing for certification, scoping internal audit cycles, or onboarding AI systems into an existing ISMS (27001) / QMS (13485) program. NOT an executive AI strategy skill (see chief-ai-officer-advisor). NOT EU AI Act compliance (see compliance-team-eu-ai-act).
3k est. installs25k stars - legal
iso42001-specialist
ISO/IEC 42001:2023 AI Management System (AIMS) specialist for compliance teams running internal audits. Three decisions: (1) Where are the gaps against Clauses 4-10 and what do we close first? (2) What goes in the AI risk register and which Annex A controls treat each risk? (3) What's the 12-month internal audit plan that satisfies Clause 9.2? Use when preparing for certification, scoping internal audit cycles, or onboarding AI systems into an existing ISMS (27001) / QMS (13485) program. NOT an executive AI strategy skill (see chief-ai-officer-advisor). NOT EU AI Act compliance (see compliance-team-eu-ai-act).
3k est. installs25k stars - legal
mdr-745-specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').
3k est. installs25k stars - legal
patent
Patent prior-art and landscape intelligence skill — not generic patent help. Commits to one of five sub-use-cases via forcing intake (novelty search / freedom-to-operate / competitive landscape / acquisition diligence / litigation prior-art) before any search runs. Searches Google Patents, Espacenet, USPTO, and optionally Lens.org for citation-graph signals. Output is an editable Word document (.docx) with verdict, ranked closest art (claim-text extracted), CPC-class-aware landscape, family-resolved hits, geographic coverage, FTO flags where applicable, strategy recommendations, and full audit log. Use when the user asks for patent searching or analysis (e.g., 'prior art search for [invention]', 'freedom to operate analysis for [product]'). Produces search signal, not legal advice — always recommends consulting a patent attorney before filing or licensing decisions. Trademark, copyright, and trade-secret questions are out of scope.
3k est. installs25k stars - legal
qms-audit-expert
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.
3k est. installs25k stars - legal
quality-documentation-manager
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.
3k est. installs25k stars - legal
quality-manager-qmr
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.
3k est. installs25k stars - legal
quality-manager-qms-iso13485
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.
3k est. installs25k stars - legal
ra-qm-skills
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').
3k est. installs25k stars - legal
regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
3k est. installs25k stars - legal
risk-management-specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
3k est. installs25k stars - legal
soc2-audit-prep
/cs:soc2-audit-prep <scope> — SOC 2 Type II readiness 6-question forcing interrogation. Observation-period focused. Use before Type II observation begins, mid-period checkpoint, or pre-field-test month-10 readiness.
3k est. installs25k stars - legal
soc2-compliance
Use when the user asks to prepare for SOC 2 audits, map Trust Service Criteria, build control matrices, collect audit evidence, perform gap analysis, or assess SOC 2 Type I vs Type II readiness.
3k est. installs25k stars