Results for “mdr”

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, and EUDAMED integration.

Transform verbose documentation into concise, example-driven tldr command references following the tldr-pages project standards.

Update docs/index.md and write Google-style docstrings for NeMo-RL documentation changes.

Creates and manages Architecture Decision Records using the Michael Nygard format, including new ADR creation, retrospective analysis, superseding, deprecating, and index generation.

Maintains a project's domain vocabulary and records architecturally-significant decisions as they're made — a CONTEXT.md glossary and gated ADRs, not passive documentation read once. Use when terminology conflicts or turns fuzzy, when making a decision that's hard to reverse/surprising/a real trade-off, or when a stated domain rule doesn't match what the code actually does.

Converts long-form markdown documents (specs, RFCs, reports, plans) into a single-file HTML page with sticky table of contents, scrollspy, search filter, code-copy buttons, and customizable design tokens.

Read every ADR markdown file in docs/adr before making or reviewing decision-sensitive changes. Use when architecture, conventions, or tradeoffs are involved.

Runs a structured interview that stress-tests a plan against the project's domain model, sharpens terminology, and updates CONTEXT.md and ADRs inline as decisions are made.

Extract project vision and decisions from a user through iterative Q&A, then convert them into clear repo documentation (README, ADRs, lessons). Use when user asks to document ideas in their head.

Converts a markdown deck into a single-file HTML presentation with keyboard navigation, presenter mode, and print-to-PDF support.

Document architectural decisions in standardized ADR format. This skill should be used when making significant technical decisions, choosing between approaches, establishing patterns, or when other skills (create-plan, implement-plan, brainstorm) identify decisions that need documentation. Triggers on "document decision", "create ADR", "architectural decision", or automatically when invoked by other skills during planning and implementation.

Routes compliance requests to the appropriate regulatory and quality-management skill among 15 bundled options, covering ISO 13485, EU MDR, FDA submissions, ISO 14971, CAPA, document control, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2, and auditing.