How to Architect Scalable SaMD Systems Without Breaking Compliance

Building scalable Software as a Medical Device (SaMD) systems isn’t just about performance — it’s about maintaining regulatory compliance, traceability, and security while your system grows. If you're a developer or architect working in healthtech, this guide breaks down how to scale SaMD systems the right way. Understanding the Core Problem SaMD systems operate under strict regulations, such as: FDA (21 CFR Part 820) ISO 13485 (Quality Management) IEC 62304 (Medical Software Lifecycle) Unlike typical SaaS apps, you can’t just “move fast and break things.” Every change must be: Traceable Validated Documented 🏗️ Scalable SaMD Architecture (High-Level) A scalable and compliant SaMD system typically includes: [Frontend UI] ↓ [API Gateway] ↓ [Microservices Layer] ↓ [Compliance & Audit Layer] ↓ [Secure Data Storage] Key Principles: Loose coupling (microservices) Centralized logging & audit trails Version-controlled deployments Secure, compliant infrastructure (HIPAA/GDPR ready) 1. Build a C