cs-quality-regulatory

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.

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.

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.

Document 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.

Audit datasets for completeness, consistency, accuracy, and validity. Profile data distributions, detect anomalies and outliers, surface structural issues, and produce an actionable remediation plan.

Query the LLM Wiki — reads index.md first, drills into 3-10 relevant pages, synthesizes an answer with inline [[wikilink]] citations, and offers to file the answer back as a new comparison or synthesis page. Usage /wiki-query "<question>"

Show recent entries from the LLM Wiki log (wiki/log.md). Uses the standardized

Run a health check on the LLM Wiki vault — mechanical checks (orphans, broken links, stale pages, missing frontmatter, log gap, duplicates) plus semantic checks (contradictions, cross-reference gaps, concepts missing their own page). Outputs a markdown report with suggested actions. Usage /wiki-lint [--stale-days N] [--log-gap-days N]

Bootstrap a fresh LLM Wiki vault with the three-layer structure, schema files, and starter templates. Usage /wiki-init <path> --topic "<topic>" [--tool all|claude-code|codex|cursor|antigravity]

Ingest a source file from raw/ into the LLM Wiki — read, discuss, write summary page, update cross-references across 5-15 pages, regenerate index, append to log. Usage /wiki-ingest <path-to-source>

Track technical changes with structured records, a state machine, and session handoff. Usage: /tc <init|create|update|status|resume|close|export|dashboard> [args]

Use when the user asks to track technical changes, create change records, manage TC lifecycles, or hand off work between AI sessions. Covers init/create/update/status/resume/close/export workflows for structured code change documentation.