Software Requirements Specification (IEC 62304)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
A structured Software Requirements Specification aligned to IEC 62304 §5.2 and IEC 82304-1. It covers intended use, minimum IT requirements per MDR Annex I §17.2, functional and non-functional requirements with unique permanent IDs, ISO 14971 risk-control indicators, per-requirement IEC 62304 safety class, and traceability references to architecture, test cases and the risk management file. Fully editable Word template, roughly 75–80% deliverable.
€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.