Software of unknown provenance (SOUP) and off-the-shelf (OTS) software-It's role in developing medical devices

SOUP & OTS Software in Medical Devices

SOUP & OTS software in medical devices play a critical role in accelerating development and reducing costs. However, SOUP & OTS software in medical devices also introduce risks related to reliability, cybersecurity, and patient safety, since they are developed by third parties.

What Is SOUP & OTS Software in Medical Devices?

SOUP (Software of Unknown Provenance): Open-source, cloud-based, or commercial libraries not originally built for medical use.
OTS (Off-The-Shelf) Software: Ready-made commercial software integrated into devices with minimal modification.

The FDA requires that SOUP & OTS software in medical devices meet the same safety, validation, and quality standards as custom-developed software.

Risk Management & Compliance

Manufacturers must validate, test, and document all SOUP & OTS software in medical devices, conduct risk assessments, and maintain a Software Bill of Materials (SBOM) to track components and vulnerabilities. Proper management of SOUP & OTS software in medical devices ensures regulatory compliance, system integrity, and patient safety.

When handled correctly, SOUP & OTS software in medical devices improve efficiency while maintaining safety and performance standards.