FormlyAI

Software Architecture

Use this Software Architecture template to document the structural design and interconnections of your medical device software in compliance with IEC 62304. You should complete this template during the design and development phase to clearly define software items, their relationships, security measures, and system requirements, ensuring alignment with regulatory expectations and facilitating clear communication among development and regulatory teams. This document is essential for traceability, risk management, and future modifications or audits.
Loading markdown content...
CTA Background

Ready to generate your document?

Talk to usNo commitments required