Software Traceability Matrix (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 establishing end-to-end traceability across the software lifecycle, as required by IEC 62304 (e.g. Clauses 5.1.1 c and 7.3.3) and expected by Notified Bodies and the FDA. It links system requirements, software requirements, architecture, risk controls, and verification evidence.
What is included
- System requirements ↔ software requirements traceability
- Software requirements ↔ architecture items and units
- Hazardous situations ↔ risk control measures ↔ verifying tests (7.3.3)
- Requirements ↔ verification test cases and results
- SOUP items ↔ requirements and anomaly evaluations
- Gap-detection columns to flag orphan requirements and untested items
- Guidance notes for maintaining traceability under change control
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
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.