Software Requirements Specification (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 Word template for the Software Requirements Specification required by IEC 62304 Clause 5.2. The SRS translates system requirements and risk controls into complete, unambiguous, verifiable software requirements.
What is included
- Requirement categories per 5.2.2: functional, performance, interfaces, alarms, security, usability-related, data, installation, maintenance
- Risk control measures implemented in software (5.2.3)
- Unique requirement IDs ready for traceability
- Verification criteria per requirement
- Re-evaluation of the risk analysis trigger (5.2.4)
- Requirements review and approval record (5.2.6)
- Cross-references to IEC 62366-1 use specifications
Format
1 Microsoft Word .docx file (fully editable) + 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
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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.