SOUP List & Evaluation Record (IEC 62304)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
What it is: a professionally drafted template for identifying and evaluating Software of Unknown Provenance (SOUP) as required by IEC 62304 Clauses 5.3.3, 5.3.4, 7.1.2–7.1.3, and 8.1.2. It provides a controlled record of every SOUP item, its requirements, and its risk evaluation.
What is included
- SOUP register: title, manufacturer, unique version/designator (8.1.2)
- Functional and performance requirements per SOUP item (5.3.3)
- Hardware/software environment requirements (5.3.4)
- Evaluation of published anomaly lists (7.1.3)
- Contribution to hazardous situations analysis (7.1.2)
- Update/obsolescence monitoring and re-evaluation triggers
- Ready-made link to the cybersecurity vulnerability monitoring process (SBOM-friendly)
Format
1 fully editable file + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.
Need the full lifecycle?
This is 1 of 12 templates in the IEC 62304 & Cybersecurity Documentation Kit.
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.