From domain-healthcare
Medical device software development covering IEC 62304 software lifecycle, ISO 14971 risk management, design controls, software verification and validation, FDA regulatory submissions, software change control, and cybersecurity for medical devices.
npx claudepluginhub rnavarych/alpha-engineer --plugin domain-healthcareThis skill is limited to using the following tools:
- Classifying software safety class (A, B, or C) under IEC 62304
Searches, retrieves, and installs Agent Skills from prompts.chat registry using MCP tools like search_skills and get_skill. Activates for finding skills, browsing catalogs, or extending Claude.
Searches prompts.chat for AI prompt templates by keyword or category, retrieves by ID with variable handling, and improves prompts via AI. Use for discovering or enhancing prompts.
Guides implementation of event-driven hooks in Claude Code plugins using prompt-based validation and bash commands for PreToolUse, Stop, and session events.
references/iec62304-lifecycle.md — software safety classification table, 9-step lifecycle processes, required documentation artifacts (SDP, SRS, SAD, SDD, test plans, traceability matrix)references/iso14971-risk-design-controls.md — ISO 14971 risk management process, risk control hierarchy, risk acceptability matrix, design inputs/outputs, design review, design verification and validationreferences/vv-fda-cybersecurity.md — V&V definitions, requirements traceability, code coverage by class, static analysis tools, 510(k)/PMA/De Novo pathways, change control classification, FDA cybersecurity guidance, SBOM, coordinated vulnerability disclosure