Results for “mdr”

Grill the user relentlessly about a plan, decision, or idea. Use when the user wants to stress-test their thinking, or uses any 'grill' trigger phrases.

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Write or rewrite technical text with the rules of ASD-STE100 Simplified Technical English so it is clear, unambiguous, and free of AI slop. Use for documentation, READMEs, runbooks, procedures, error messages, release notes, incident reports, and API guides. Also use when the user says "STE", "Simplified Technical English", "ASD-STE100", "de-slop", "make this readable", "write for non-native readers", or asks for docs that translate well. Enforces the standard's 53 rules: 20/25-word sentence limits, one word one meaning, simple tenses, active voice, condition before command.

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Use when you need to resolve an in-progress git merge/rebase conflict.

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Implement a piece of work based on a spec or set of tickets.

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Maintain CHANGELOG.md — add new version entries, keep the Unreleased section, cut a release, or restructure the whole file — following the Keep a Changelog format and Semantic Versioning.

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Search and explore an Obsidian vault through the NoteBrain CLI (semantic search, tags, backlinks, connections, hidden links, boosted retrieval). Use it whenever the user mentions their notes, knowledge base, Obsidian vault, semantic search, finding connections or unlinked notes, or asks exploratory questions like "what do I know about X", "find notes related to Y", "what connects to Z", or "summarize my notes on W" — even when they never say NoteBrain, vector search, or ChromaDB.

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Create a concise, evidence-backed implementation plan and save it to .agents/plans/Plan.md. Use when the user asks to plan a feature or task.

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Execute an approved plan from .agents/plans/Plan.md in a fresh session. Use when handed an approved plan to implement.

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Review the changes since a fixed point (commit, branch, tag, or merge-base) along two axes — Standards (does the code follow this repo's documented coding standards?) and Spec (does the code match what the originating issue/spec asked for?). Runs both reviews in parallel sub-agents and reports them side by side. Use when the user wants to review a branch, a PR, work-in-progress changes, or asks to "review since X".

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Writing documents for agents. Use when creating or editing skills, or modifying AGENTS.md or CLAUDE.md.

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Teach the user a new skill or concept, within this workspace.

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Test-driven development. Use when the user wants to build features or fix bugs test-first, mentions "red-green-refactor", or wants integration tests.

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Create new skills, modify and improve existing skills, and measure skill performance. Use when users want to create a skill from scratch, edit, or optimize an existing skill, run evals to test a skill, benchmark skill performance with variance analysis, or optimize a skill's description for better triggering accuracy.

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Checks a master document register extract for gaps and returns a DRAFT question list for document control: missing or out-of-sequence revisions, overdue or slipping deliverables, numbering that breaks the project convention, duplicates and incomplete rows, each with row, test and quoted evidence. Never edits the register, re-baselines a date or marks a deliverable complete. Use when the user asks to "check the MDR", "find the gaps in the deliverables list" or "prepare questions on the drawing register". Do not use for drafting a transmittal from a document list, use transmittal-drafter instead. Drafts for human review; never approves, authorises or signs off.

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Reconstructed reference notes on US FDA medical-device software regulation, built from seven public-domain FDA sources (the QMSR final rule 89 FR 7496, FDA device software guidance documents, and the eSTAR program page; pinned 2026-10-12). Use for regulatory pathways and premarket submissions (510(k), De Novo, PMA, eSTAR), premarket software documentation levels (Basic or Enhanced), software validation and Computer Software Assurance, the Quality Management System Regulation (QMSR, 21 CFR 820), medical-device cybersecurity (secure product development, SBOMs, FD&C Act section 524B, labelling), clinical decision support boundaries, off-the-shelf software, MDDS and other software-function scope questions, and the 510(k) software-change trigger. SCOPE LIMITS: US FDA device regulation only; no EU MDR or UKCA content (see `med-device-eu`); no ISO 13485, ISO 14971, or IEC 62304 text, which are named and summarized only as FDA obligations; no drug, biologic, or combination-product rules; reflects the pinned source dates, not later FDA actions; synthesized reference notes, not legal advice and not a substitute for the guidance documents. LICENCE: Public Domain (US Government work, 17 U.S.C. 105).

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AiZynthFinder retrosynthetic route planning (CASP) from AstraZeneca Molecular AI. Monte Carlo tree search guided by a template-based neural expansion policy recursively disconnects a target SMILES until precursors are found in a purchasable stock. Covers config.yml (v4 format), aizynthcli batch screening, the AiZynthFinder/AiZynthExpander Python API, one-step disconnections, custom stocks via smiles2stock, scorers, Retro*/breadth-first/DFPN search alternatives, and reading output.json.gz / trees.json. Use for synthesis route planning, synthesizability screening, and building-block/precursor search. For reaction barriers use neb-irc-activation-energy; for 2D reaction scheme drawing use rdkit-chemdraw-cdxml.

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Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance

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Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

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