IEC 62304 Medical Device Software Lifecycle
CommunityIEC 62304-compliant medical device lifecycle.
Legal & Compliance#documentation#risk-management#regulatory-compliance#medical-devices#iec-62304#software-lifecycle
Authorgitjfmd
Version1.0.0
Installs0
System Documentation
What problem does it solve?
Provides IEC 62304-aligned guidance for managing the medical device software lifecycle within AI coding agents, enabling compliant development, maintenance, and documentation.
Core Features & Use Cases
- Regulatory-aligned lifecycle guidance for software development, risk management, verification, and documentation.
- Supports traceability and compliance with ISO 14971, FDA, and EU MDR.
- Use Case: Integrate this skill in a software project to ensure lifecycle processes are followed from design through maintenance in a regulated medical device context.
Quick Start
Activate this skill to begin IEC 62304-aligned lifecycle guidance for your medical device software project.
Dependency Matrix
Required Modules
None requiredComponents
Standard package💻 Claude Code Installation
Recommended: Let Claude install automatically. Simply copy and paste the text below to Claude Code.
Please help me install this Skill: Name: IEC 62304 Medical Device Software Lifecycle Download link: https://github.com/gitjfmd/open-medical-skills/archive/main.zip#iec-62304-medical-device-software-lifecycle Please download this .zip file, extract it, and install it in the .claude/skills/ directory.
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