meddev-software-configuration-management

by Medical Device Skills

Implement 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. Use when working on software configuration management in medical device software.

v1.0.0New

#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-meddev-software-configuration-management

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-meddev-software-configuration-management --target claude-code

Instructions

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meddev-authenticationDefine secure user/device authentication, session management, and RBAC suitable for medical device risk profiles. Use when working on authentication in medical device software.0 installs meddev-state-machinesDefine explicit, testable state machines with safe states, controlled transitions, and error handling suited to medical device safety classes. Use when working on state machines in medical device software.0 installs meddev-change-controlDefine controlled change-request workflow for software: impact analysis, approvals, verification scope, and regulatory submission flags. Configuration identification and baselines are in DOC-SCM (IEC 62304 Clause 8.1, 8.3); approved implementation and re-verification align with 8.2. Use when working on change control in medical device software.0 installs CONN-USBImplement safe USB device connectivity: class selection, enumeration handling, data validation, electrical and safety considerations.0 installs meddev-ai-ml-medical-device-softwareAddress machine learning inside the regulated product (not LLM coding assistants): Good Machine Learning Practice (GMLP), training/validation data integrity, Predetermined Change Control Plans (PCCP) where applicable, drift monitoring, and linking models to ISO 14971 and software lifecycle controls. Use when working on ai ml medical device software in medical device software.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

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DATA-AUDITDefine what and how to log for medical devices: security/safety events, integrity, protection, and retention of logs for compliance and forensics.2 installs ARCH-SEPARATIONDefine architectural partitioning to contain failures, simplify verification, and align safety classes with appropriate isolation.1 installs DOC-DESIGN-DOCSGuide creation and maintenance of Software Architecture (SAD) and Design Descriptions (SDD) that support safety, traceability, and compliance.1 installs DATA-INTEGRITYEnsure integrity of data in storage and transmission using checksums/CRCs/ECC, validation, and redundancy where needed for medical devices.1 installs TEST-UNITEstablish patterns for unit tests that verify software units against requirements with safety-class-appropriate rigor.1 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

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Frequently asked questions about meddev-software-configuration-management

What does the meddev-software-configuration-management skill do?

How do I install the meddev-software-configuration-management skill?

Run `npx @skills-hub-ai/cli install meddev-skills-meddev-software-configuration-management` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/meddev-skills-meddev-software-configuration-management/ 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 meddev-software-configuration-management work with?

meddev-software-configuration-management 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 meddev-software-configuration-management 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 meddev-software-configuration-management after installing it?

In Claude Code, type `/meddev-skills-meddev-software-configuration-management` (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 meddev-software-configuration-management 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.