By tractorjuice
Generate UK NHS clinical safety case reports, hazard logs, and DTAC v3 assessments for medical devices and health IT systems, plus determine SaMD/AIaMD classification under UK and EU MDR.
[COMMUNITY] Determine medical-device classification for software-as-medical-device (SaMD) or AI-as-medical-device (AIaMD) under UK MDR 2002 (as amended) and EU MDR 2017/745, including UKCA / UKNI / CE marking pathway and Windsor Framework NI handling.
[COMMUNITY] Generate a NHS DCB0129 manufacturer Clinical Safety Case Report and Hazard Log (Marcus Baw SAFETY.md 3-file spec) for a digital health product placed on the NHS market.
[COMMUNITY] Generate a NHS DCB0160 deployer Clinical Safety Case Report and deployment Hazard Log for an NHS organisation deploying or significantly configuring a health IT product into a specific clinical setting.
[COMMUNITY] Generate an NHS Digital Technology Assessment Criteria (DTAC v3) assessment for a digital health product being procured or assured by an NHS organisation.
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npx claudepluginhub lllc-lllc/arc-kit --plugin arckit-uk-nhsAustrian Overlay for ArcKit — 3 commands for DSG/DSGVO, NISG, and Bundesvergabegesetz public procurement. Requires arckit core plugin.
French Public Sector Overlay for ArcKit — 12 commands for DINUM, ANSSI, RGPD/CNIL, EBIOS, PSSI, SecNumCloud, Diffusion Restreinte, public procurement, and ANSSI cartography. Requires arckit core plugin.
Canadian Federal Overlay for ArcKit — 12 commands for AIA, ATIP, ITSG-33, GC Digital Standards, OCAP, OLA, and federal cloud residency. Requires arckit core plugin.
EU Overlay for ArcKit — 7 commands for GDPR, AI Act, DSA, DORA, Data Act, NIS2, and CRA. Requires arckit core plugin.
UK G-Cloud Supplier Bid-Authoring Overlay for ArcKit — 11 supplier-side commands that drive a G-Cloud 14 Digital Marketplace submission end to end: supplier profile, service design, Service Definition Documents (Lots 1/2/3), supplier declaration, pricing, NCSC Cloud Security Principles assertions, competitor benchmark, submission review, and CCS submission packaging. Recipe: uk-gcloud-submission. Requires arckit core plugin. PROPRIETARY — not covered by the repository MIT licence. EXPERIMENTAL.
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Claude Code skill pack for OpenEvidence medical AI (24 skills)
Establish architecture governance, design fitness functions, manage tech debt, and ensure compliance. Build sustainable architecture practices.
🏛️ Enterprise Architecture Strategist — Enterprise Architecture Strategist + TOGAF ADM Navigator + C-Suite Technology Translator
Validate AI medical devices, manage PCCPs, monitor adverse events, and stay aligned with FDA QSR
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