DOC-DESIGN-DOCS

by Medical Device Skills

Guide creation and maintenance of Software Architecture (SAD) and Design Descriptions (SDD) that support safety, traceability, and compliance.

v1.1.0New

#meddev-skills

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Install this skill

Run this command in your terminal. No account required — it auto-detects your AI tool and installs the skill file.

npx @skills-hub-ai/cli install meddev-skills-doc-design-docs

Or download directly:

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Setup by platform

Claude Code

~/.claude/skills/<skill>/SKILL.md

Setup guide →

Install

One-click setup for your editor

Run in your project root

npx @skills-hub-ai/cli install meddev-skills-doc-design-docs --target claude-code

Instructions

This skill doesn’t include stateful context yet, instructions only. Learn about stateful skills.

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CONN-USBImplement safe USB device connectivity: class selection, enumeration handling, data validation, electrical and safety considerations.0 installs TEST-HILValidate software with real or representative hardware, sensors, actuators, and timing, to uncover integration and safety issues not visible in simulation.0 installs ARCH-SEPARATIONDefine architectural partitioning to contain failures, simplify verification, and align safety classes with appropriate isolation.0 installs REG-21CFR11Provide implementation guidance for electronic records/signatures (ER/ES) compliance: access control, audit trails, data integrity, and validation expectations in medical device software and supporting tools.0 installs REG-FDA820Map **21 CFR Part 820 Subpart C — Design Controls** to software lifecycle work: design planning, inputs, outputs, review, verification, validation, transfer, and DHF/DMR links, including how **software validation** (intended use / risk controls) complements **verification** (requirements and specs). Includes a concise **ISO 13485:2016** slice where it overlaps QMS expectations for design and risk (interpretation; align with your notified-body MDSAP scope for EU).0 installs CICD-RELEASEDefine controlled release process for medical device software: versioning, branching, verification, approvals, documentation, and post-release monitoring.0 installs

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FW-MEMORYEnsure deterministic and safe memory usage: static allocation, pools, stack sizing, MPU usage, and corruption detection for medical device firmware.0 installs SEC-KEYMGMTDefine generation, storage, rotation, revocation, and provisioning of cryptographic keys for medical devices, supporting secure boot, OTA, and comms.0 installs TEST-COVERAGEMeasure and enforce coverage appropriate to safety class: statement/branch and MC/DC where applicable, with documented exclusions.0 installs DOC-SCMImplement identification, change control, and status accounting for software configuration items per IEC 62304:2006+A1:2015, Clause 8—ensuring reproducible baselines, controlled SOUP records, and retrievable history separate from change-request workflow details in `DOC-CHANGE-CONTROL`.0 installs REG-EU-MDRProvide actionable guidance for software under EU MDR, focusing on classification (Rule 11), technical documentation expectations, UDI for software, PMS/PMCF needs, and alignment with MDCG guidance.0 installs DOC-SW-MAINTGuide post-release software maintenance per IEC 62304:2006+A1:2015, Clause 6—planning feedback handling, evaluating problems and changes, re-applying development activities when needed, and re-releasing under the same controls as initial release (5.8).0 installs

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adrCreate and manage Architecture Decision Records using the Michael Nygard format. Supports new ADR creation, retrospective analysis to document existing decisions, superseding, deprecating, and index generation. Use when you need to document architecture decisions, record technical choices, explain why a technology was chosen, or create decision logs.4 installs blog-writerWrite human-sounding, SEO-optimized blog posts for skills-hub.ai. Use when: 'write a blog post', 'draft a post', 'update blog', 'blog about', 'write about'. Supports styles: tutorial, deep_dive, opinion, listicle, case_study.4 installs api-docsGenerate OpenAPI 3.1 documentation from your API codebase. Auto-detects Express, Fastify, NestJS, Django, FastAPI, Flask, Rails, Spring, Go, and more. Extracts routes, request/response schemas, auth requirements, and validation rules. Sets up interactive docs with Swagger UI, Redoc, or Scalar. Use when you need API documentation, OpenAPI spec, Swagger docs, endpoint reference, or REST API docs.3 installs readmeGenerate project documentation — README files, API docs, and changelogs. Triggers: README, documentation, generate docs, document this project, write README, API docs, changelog.2 installs excalidrawGenerate Excalidraw architecture diagrams (.excalidraw JSON files) from your codebase. Produces hand-drawn-style C4 context and container diagrams, sequence diagrams for key flows, ER diagrams from database schemas, and module dependency graphs. Use when you need whiteboard-style sketches that read as a thinking artifact rather than a polished spec — ideal for design docs, onboarding, and slide decks. Complements the `diagram` skill (which produces Mermaid).1 installs documentAudit your project's documentation health and identify gaps. Scans for README, changelog, API docs, ADRs, runbooks, onboarding guides, and diagrams. Scores coverage against project maturity tier and recommends specific sub-skills to fill missing docs. Use when you need a documentation audit, want to check doc coverage, find missing documentation, or assess documentation quality.1 installs

Frequently asked questions about DOC-DESIGN-DOCS

What does the DOC-DESIGN-DOCS skill do?

Guide creation and maintenance of Software Architecture (SAD) and Design Descriptions (SDD) that support safety, traceability, and compliance. It's a reusable SKILL.md instruction set that loads into your AI coding assistant on demand, no prompt engineering, no copy-pasting every session.

How do I install the DOC-DESIGN-DOCS skill?

Run `npx @skills-hub-ai/cli install meddev-skills-doc-design-docs` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/meddev-skills-doc-design-docs/ for Claude Code or ~/.cursor/skills/ for Cursor with --target cursor) and adds it to your project's .skills.json lockfile.

Which AI tools does DOC-DESIGN-DOCS work with?

DOC-DESIGN-DOCS runs in Claude Code. It follows the open Agent Skills standard (SKILL.md), so the same skill works in every supported tool without modification.

Is the DOC-DESIGN-DOCS skill free?

Yes. Every skill on skills-hub.ai is free and open-source. There are no premium tiers, paywalls, or usage limits. You only pay for whatever AI assistant you're already using.

How do I use DOC-DESIGN-DOCS after installing it?

In Claude Code, type `/meddev-skills-doc-design-docs` (or whatever slash command the skill registers) and the AI follows the skill's instructions immediately. You can also reference it by name in natural language, your AI loads the skill into context when relevant.

Can I share the DOC-DESIGN-DOCS skill with my team?

Yes. Commit your project's .skills.json lockfile and teammates run `npx @skills-hub-ai/cli install` (no args) to install every skill at the exact version you pinned. Organization-scoped installs work via skills-hub.ai organizations.