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
A per-release Software Release & Configuration Management Record to IEC 62304 §5.8 and §8.1. It provides unique release identification with semantic versioning, the locked configuration baseline (software components, SOUP versions, build environment), delivery details, and a release-gate checklist that must be approved before transfer to production or distribution. Fully editable Word template, one record per release.
€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.