Software Traceability Matrix (IEC 62304)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
An active Excel traceability matrix implementing IEC 62304 §5.1.1(c). It links each requirement (SW-03) to its architecture element (SW-02), test cases (SW-06/SW-07), ISO 14971 risk-control reference and anomalies (SW-09), with an auto-calculated coverage summary that automatically flags any requirement lacking a test case. Includes a GMLP-principle column for AI-enabled software. Delivered as a fully editable Excel workbook with worked example rows.
€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.