FormlyAI

Software of Unknown Provenance (SOUP) List

Use this Software of Unknown Provenance (SOUP) List template to systematically document all third-party or legacy software components incorporated into your medical device, detailing their associated risks, requirements, and placement within your software architecture. Completing this template is essential during software development and risk management activities to ensure regulatory compliance, facilitate risk assessments, and support traceability of SOUP components throughout the device lifecycle.
Loading markdown content...
CTA Background

Ready to generate your document?

Talk to usNo commitments required