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
An Excel SOUP (Software of Unknown Provenance) register and evaluation record per IEC 62304 §8 and IEC 81001-5-1. It captures each SOUP item’s version, function in the device, assigned safety class with rationale, required verification activities, CVE screening, monitoring status and a complete re-evaluation history log. Includes an AI-component and dataset-provenance column for AI-enabled software. Delivered as a fully editable Excel workbook with worked examples.
€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.