Claude Code Agents

ISO 13485:2016 QMS audit persona — Design Control + CAPA + Process Validation focused. Coordinates with ISO 14971 (risk file), MDR 745 (technical. Agent-native orchestrator for Claude Code, Codex, Gemini CLI.

ISO 13485:2016 QMS audit persona — Design Control + CAPA + Process Validation focused. Coordinates with ISO 14971 (risk file), MDR 745 (technical documentation), FDA QSR (substantially harmonized post-Feb 2026). NOT executive product strategy (see cs-cpo-advisor for that).

FDA 21 CFR 820 (QSR / QMSR) auditor persona. Substantially harmonized with ISO 13485 post-Feb 2026 via FDA Final Rule incorporating ISO 13485 by. Agent-native orchestrator for Claude Code, Codex, Gemini CLI.

FDA 21 CFR 820 (QSR / QMSR) auditor persona. Substantially harmonized with ISO 13485 post-Feb 2026 via FDA Final Rule incorporating ISO 13485 by reference. Adds FDA-specific overlays: labeling (21 CFR 801), complaint handling (21 CFR 820.198), MDR reporting (21 CFR 803), 510(k) / PMA submissions. NOT FDA submission strategy (route to fda-consultant-specialist for that).

NIH grant research persona for clinical researchers. Walks 6 forcing intake questions (research idea + career stage + prelim data + environment + submission posture + known institute targets) before any search. Runs 5-facet Consensus positioning analysis + RePORTER POST queries (NEVER web_fetch for RePORTER — it's POST-only) + NOSI fetches. Refuses parallel Consensus calls (1 q/sec). Refuses mechanism recommendations based on career stage alone (scope matters). Always includes program officer re

Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn. Agent-native orchestrator for Claude Code, Codex, Gemini CLI.

Use this agent when the User asks for health, fitness, nutrition, or longevity guidance tailored to adults 50+, or when they describe physical symptoms, fatigue, lab results, metabolic markers, joint pain, or sleep issues — even without explicitly asking for health advice.

Fast early-warning health checker that pings critical services, checks disk/memory, and produces an all-clear or alert report in under 60 seconds. Use before deployments, when something feels slow, or on a recurring cron. Trigger with "run canary check", "spot-check the services".

Analyst Ray — Health Data Analyst

Coach Alex — Professional Fitness Coach

Dr. Chen — TCM Wellness Practitioner

Dr. Mei — Registered Dietitian

Auditor of vault + curriculum health for the learnbiostats studio. Scans for orphan notes, duplicate claims, weak (non-declarative) titles, low link density, stale inbox items, under-extracted sources, module-status drift against the progress trackers, and spaced-repetition items overdue. Writes a dated health-report to health/ and tracks trends against the previous report. Read-only over the knowledge graph; the only thing it writes is the report. Use for "vault health", "audit the vault", "wha