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
What it is: a professionally drafted template implementing the software problem resolution process required by IEC 62304 Clause 9. It provides a controlled log of problem reports and anomalies from development through post-market maintenance, with clear links to change control and vigilance.
What is included
- Problem report register with unique IDs, type, scope, and criticality (9.1)
- Investigation and safety impact evaluation, including risk management interface (9.2)
- Advisory notice / regulator communication decision point (9.3)
- Link to change control process (9.4, 8.2)
- Verification of problem resolution and regression check (9.7)
- Trend analysis fields (9.6) feeding PMS and maintenance
- Residual anomaly disposition ready for the release record
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. Save [X%] with the bundle: EUR [KIT-PRICE] vs EUR [SUM-PRICE] buying individually.
€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.