菜单
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.
用 Codex 或 Claude 帮你安装 复制这段 Prompt，粘贴到 Codex、Claude 或其他助手里，让它检查 Skill 页面并帮你完成安装。
基于 SOC 职业分类
Guides on AI/ML system design, LLM application architecture, MLOps pipelines, AI SaaS platform selection (OpenAI, Anthropic, Google Vertex AI, AWS Bedrock, Azure OpenAI, Hugging Face, Cohere, Replicate, Together AI), model serving, feature stores, experiment tracking, evaluation frameworks, RAG architecture, AI agent patterns, responsible AI, cost optimization, and emerging AI/ML trends. Use when designing AI systems, selecting AI providers, building LLM applications, setting up MLOps, or evaluating AI architecture patterns.
AI/LLM integration patterns: Anthropic SDK streaming with TypeScript, RAG architecture (chunking, embedding, vector search with pgvector), tool use / function calling, model selection guide (Haiku 4.5 vs Sonnet 5 vs Opus 4.8), prompt caching, structured output with Zod, token cost management. Use when building AI features, RAG pipelines, AI agents.
Flutter 3.27+ patterns — Riverpod 2 state with codegen, GoRouter 14+ navigation, Impeller rendering (default on all platforms), WASM web, extension types, on-device AI (firebase_ai, MediaPipe), Patrol 3.x testing, platform channels, performance
Expert guidance on Flutter 3.27+ (Impeller default on all platforms, Material 3, WASM web, DevTools, Flame), Dart 3.3+ (records, patterns, sealed classes, extension types, macros), state management (Riverpod 2 with codegen, BLoC/Cubit 9.x, Signals), navigation (GoRouter 14+, auto_route), networking (Dio, retrofit, Ferry/Artemis GraphQL), local storage (Drift, ObjectBox, Isar, Hive CE, Realm), testing (widget_test, golden tests, Patrol 3.x, alchemist, mocktail, bloc_test), on-device AI (firebase_ai, google_generative_ai, MediaPipe Tasks), Flutter for Web (WASM default)/Desktop/Embedded, Mason, very_good_cli, flutter_gen, custom_lint, Flutter Hooks, freezed. Use when building or optimizing Flutter apps.
Designs CI/CD pipelines with build, test, and deploy stages, blue-green/canary/rolling deployments, feature flags, artifact management, and environment promotion strategies. Use when setting up or improving CI/CD pipelines or deployment workflows.
Designs REST, GraphQL, gRPC, tRPC, WebSocket, SSE, and AsyncAPI/event-driven APIs. Covers OpenAPI 3.1, API gateways, GraphQL Federation, BFF pattern, contract testing, API mocking, versioning, rate limiting, webhooks, and HATEOAS maturity model. Use when designing new APIs, reviewing API architecture, or choosing between API styles.
| name | domain-healthcare:medical-device-software |
| description | 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. |
| allowed-tools | Read, Grep, Glob, Bash |
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