Software Release & Configuration Management Record (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 combining the software release record (IEC 62304 Clause 5.8) with configuration management documentation (Clause 8). It ensures every released version is uniquely identified, reproducible, and archived with its known anomalies.
What is included
- Software version identification and release designation (5.8.4)
- Configuration items register, including SOUP and tools (8.1)
- Change control record linked to problem resolution (8.2)
- Configuration status accounting (8.3)
- Archiving of software and build environment (5.8.7–5.8.8)
- Known residual anomalies communicated at release
- Procedure/environment to reliably re-create the released software
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.