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.

v1.1.01 install

#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 TEST-COVERAGEMeasure and enforce coverage appropriate to safety class: statement/branch and MC/DC where applicable, with documented exclusions.0 installs ARCH-SEPARATIONDefine architectural partitioning to contain failures, simplify verification, and align safety classes with appropriate isolation.0 installs SEC-KEYMGMTDefine generation, storage, rotation, revocation, and provisioning of cryptographic keys for medical devices, supporting secure boot, OTA, and comms.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

More from Medical Device Skills

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DATA-INTEGRITYEnsure integrity of data in storage and transmission using checksums/CRCs/ECC, validation, and redundancy where needed for medical devices.1 installs DATA-AUDITDefine what and how to log for medical devices: security/safety events, integrity, protection, and retention of logs for compliance and forensics.1 installs TEST-DASTDetect runtime defects (memory, concurrency, timing, performance, power) via dynamic tools and instrumentation in medical device software.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 DOC-CODE-COMMENTSProvide conventions for code comments that support traceability to requirements, risks, and tests, while maintaining clarity and brevity.0 installs REG-SAMD-CLINGuide **Software as a Medical Device (SaMD)** and **software in devices** for **clinical evaluation** expectations: intended use, SaMD category (IMDRF framework), evidence of **analytical and clinical validity** where applicable, and alignment with **EU MDR Annex XIV** clinical evaluation and **FDA** premarket clinical/benefit-risk expectations for software-driven diagnostics and monitoring.0 installs

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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.