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.
Full skill instructions
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
IoT security practices covering device identity with X.509 and secure elements, secure boot chains, encrypted communication (TLS/DTLS), firmware signing, network segmentation, device attestation, and vulnerability management for resource-constrained devices.
Migration planning expertise including strangler fig pattern, parallel run strategy, data migration techniques, feature parity tracking, rollback plans, phased timelines, risk mitigation, and zero-downtime migration.
State management expertise including local vs global state decisions, Redux Toolkit, Zustand, Jotai, MobX, Context API patterns, server state (React Query, SWR) vs client state, optimistic updates, and state machines with XState.
Terraform and Infrastructure as Code expertise covering HCL module design, state management, workspaces, provider configuration, drift detection, Terragrunt, infrastructure testing, and resource lifecycle management.
Test data management with factory patterns (Faker.js, Fishery, Factory Bot), database seeding, test data isolation (transactions, cleanup), anonymization and masking for production data, synthetic data generation, fixture management, and shared test state risks. Use when designing test data strat...
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
GCP architecture expertise including Google Cloud Architecture Framework, project and organization structure, VPC and networking design, data and analytics architecture, Kubernetes and serverless patterns, AI/ML platform design, security architecture, and cost optimization strategies. Use proacti...
CI/CD test integration: parallel test execution (sharding), test splitting strategies, flaky test quarantine, test reporting (Allure, ReportPortal, JUnit XML), quality gates (coverage thresholds, no new failures), test result caching, and pre-commit hooks. Use when configuring test pipelines, opt...
Monitoring and observability expertise covering Prometheus/Grafana stack, Datadog, CloudWatch, PagerDuty integration, custom metrics, dashboard design using USE/RED methods, alert routing, uptime monitoring, and log aggregation.
Vue.js expertise including Composition API, Pinia state management, Nuxt.js 3, Vue Router, custom directives, provide/inject patterns, transition system, and Volar tooling configuration.
Sets up observability: structured logging, metrics collection, distributed tracing, alerting rules, dashboard design, SLI/SLO/SLA definition. Covers ELK, Prometheus, Grafana, Datadog, OpenTelemetry. Use when implementing monitoring, debugging production issues, or designing observability architec...
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