Software Architecture & Detailed Design (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 covering the Software Architecture (IEC 62304 Clause 5.3) and Detailed Design (Clause 5.4). It documents the decomposition of the software system into items and units, their interfaces, and the design measures implementing risk controls.
What is included
- Software system decomposition into items and units
- Internal and external interface specifications
- Functional and performance requirements for SOUP items (5.3.3)
- Hardware/software requirements supporting SOUP (5.3.4)
- Segregation necessary for risk control (5.3.5), with rationale
- Detailed design of software units for Class C (5.4.2–5.4.4)
- Architecture verification checklist (5.3.6)
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
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.