Software Architecture & Detailed Design (IEC 62304)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Documents the software architecture and detailed design to IEC 62304 §5.3: system overview and context diagram, decomposition into software items and units, interface definitions, and SOUP integration points. It provides the structure reviewers expect in order to trace requirements (SW-03) down to design and up to verification (SW-06). Fully editable Word template, roughly 75–80% deliverable, to be completed with your system-specific detail.
€69.00
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.