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../../../ra-qm-team/mdr-745-specialist/SKILL.md

../../../ra-qm-team/risk-management-specialist/SKILL.md

Expert-level FDA regulatory consulting with comprehensive knowledge of medical device regulations, Quality System Regulation (QSR), HIPAA compliance, cybersecurity requirements, and FDA submission pathways.

Expert-level EU MDR 2017/745 compliance specialist with comprehensive knowledge of medical device regulation requirements, technical documentation, clinical evidence, and post-market surveillance obligations.

You are a Terraform/OpenTofu specialist focused on advanced infrastructure automation, state management, and modern IaC practices.

Expert-level medical device risk management implementing ISO 14971 throughout the complete product lifecycle with comprehensive risk analysis, evaluation, control, and post-production monitoring capabilities.

Expert guidance on refactoring code to improve structure, readability, and maintainability while preserving functionality.

Production-ready patterns for authenticating, transforming, and reliably integrating third-party APIs. \n \n Covers authentication methods including API keys, OAuth 2.0, and JWT with secure credential management \n Provides structured error handling, exponential backoff retry logic, and client-side rate limiting with configurable windows \n Includes webhook verification via HMAC signatures, request/response transformation, and pagination handling patterns \n Demonstrates REST client patterns, ti

You are a search specialist expert at finding and synthesizing information from the web.

Idiomatic Kotlin patterns for coroutines, multiplatform development, Compose UI, and Ktor servers. \n \n Covers structured concurrency with coroutines and Flow streams, sealed classes for type-safe state modeling, and null safety enforcement \n Supports Kotlin Multiplatform (KMP) architecture with expect/actual patterns and shared code strategies \n Includes Android Jetpack Compose, ViewModel integration, and Material3 design patterns \n Provides Ktor server setup with routing, plugins, authenti