القائمة
Modular skills for AI coding agents working on medical device software. Aligned to IEC 62304, ISO 14971, FDA, and EU MDR standards for software lifecycle management.
التثبيت باستخدام Codex أو Claude انسخ هذا Prompt والصقه في Codex أو Claude أو مساعد آخر ليراجع صفحة Skill ويثبّتها لك.
استنادا إلى تصنيف SOC المهني
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| name | iec-62304-compliance |
| description | Modular skills for AI coding agents working on medical device software. Aligned to IEC 62304, ISO 14971, FDA, and EU MDR standards for software lifecycle management. |
A modular skill set for AI coding agents working on medical device software development. Provides structured guidance aligned to IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), FDA 21 CFR Part 820, and EU MDR (Medical Device Regulation) standards. The skill ensures that software development activities produce the documentation, testing, and traceability artifacts required for regulatory submissions and quality system compliance.
npx skills add Open-Medica/open-medical-skills --skill iec-62304-compliance
Software safety classification:
Determine IEC 62304 software safety class for:
Device: AI-assisted insulin dosing recommendation system
Intended use: Provides insulin dose suggestions to patients with Type 1 diabetes
based on continuous glucose monitor readings and meal input
Software failure mode: Algorithm suggests incorrect dose
Potential harm: Hypoglycemia (potentially life-threatening) or hyperglycemia
(potentially leading to DKA)
IEC 62304 Software Safety Classification:
Classification: Class C (highest rigor)
Rationale:
- Software failure (incorrect dose recommendation) can directly contribute to a hazardous situation
- The hazardous situation (inappropriate insulin dose) can result in serious injury (severe hypoglycemia, seizure, loss of consciousness) or death
- No independent hardware or external safety measure can reliably prevent the harm once the incorrect dose is administered
Required IEC 62304 activities for Class C:
- Full Software Development Plan (Clause 5.1)
- Detailed Software Requirements Analysis (Clause 5.2) with traceability to risk controls
- Software Architecture Document with segregation analysis (Clause 5.3)
- Detailed Design for all software units (Clause 5.4)
- Unit-level verification for all modules (Clause 5.5)
- Integration testing at all integration levels (Clause 5.6)
- System-level testing against all requirements (Clause 5.7)
- Comprehensive Software Release documentation (Clause 5.8)
ISO 14971 risk controls to implement:
- Maximum dose limits (hard-coded safety cap)
- Rate-of-change limiting on dose adjustments
- Mandatory user confirmation before dose delivery
- Alerting for physiologically implausible dose recommendations
- Graceful degradation with safe default when sensor data is unreliable
This skill is part of Open Medical Skills, a curated marketplace of medical AI skills maintained by physicians for physicians and the healthcare industry.