Software Development Plan (IEC 62304)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
A complete Software Development Plan structured to IEC 62304 and IEC 82304-1. It establishes the device and software overview, the software safety classification (Class A/B/C) with documented rationale, the lifecycle model and planned development activities, applicable development standards, and a regulatory mapping table for Notified Body and FDA review navigation. Fully editable Word template, cross-referenced to the rest of the software documentation set. A professional, audit-ready starting point — roughly 75–80% deliverable — to be populated with your device-specific information.
€69.00
Related products
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.