Problem Resolution & Anomaly Log (IEC 62304)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
An Excel problem-resolution and anomaly log implementing IEC 62304 §9. Each anomaly is recorded with severity, safety impact, risk-file and requirement/test references, root cause, corrective action, fix version and closure sign-off, alongside an auto-calculated summary dashboard of open anomalies by severity to support release-readiness decisions. Delivered as a fully editable Excel workbook with worked examples.
€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.