SaMD IEC 62304 Software Lifecycle Toolkit
Software development plan, SRS template, architecture design, unit verification protocols, problem resolution procedure, and safety classification worksheet — structured for IEC 62304 audits.
What You Get
Software Development Plan Template (IEC 62304 Clause 5.1)
Complete software development plan covering all IEC 62304:2006+AMD1:2015 Clause 5.1 requirements: software development lifecycle model selection, deliverables, activities, standards and methods, tools, configuration management approach, and problem resolution process. Includes safety class determination impact on plan requirements (Class A vs B vs C).
Software Requirements Specification Template (IEC 62304 Clause 5.2)
Structured SRS template covering functional and non-functional requirements, SOUP requirements, interfaces, security requirements, and usability requirements per IEC 62304 Clause 5.2. Includes requirements traceability matrix to link SRS items forward to architecture, testing, and backward to system requirements and risk management.
Software Architecture Design Template (IEC 62304 Clause 5.3)
Architecture design document template covering software items identification, interface specifications, SOUP identification, and segregation of software items that implement safety measures. Structured for both Class B and Class C software with the additional architecture verification requirements for safety-critical items.
Unit Verification and Integration Test Protocol
Test protocol templates for IEC 62304 Clause 5.5 (software unit verification) and 5.6 (software integration testing). Covers unit test planning, acceptance criteria, pass/fail documentation, integration test sequences, and the regression test requirements triggered by software changes. Pre-formatted for Class B and Class C software.
Software Problem Resolution Procedure (IEC 62304 Clause 9)
Complete problem resolution procedure covering defect identification, classification, investigation, resolution, and verification. Maps to IEC 62304 Clause 9 requirements including problem report forms, resolution records, re-testing requirements, and the change control triggers that apply when problems affect released software.
Software Safety Classification Worksheet
Structured worksheet for determining IEC 62304 software safety class (A, B, or C) based on the POSSIBLE HARM analysis. Covers the injury severity assessment, probability of occurrence of harm, and the risk control measures that can reduce software safety class. Designed as a controlled QMS document linkable to your risk management file.
Why It Works
Safety class drives every template
The safety classification worksheet feeds directly into the development plan — Class A, B, and C requirements are flagged throughout each template so you only document what your class requires.
SOUP documentation built in
SOUP identification and requirements appear in the SRS and architecture templates — the documentation gap that catches most SaMD companies unprepared for IEC 62304 audits.
Traceability from requirements to tests
The SRS template includes a requirements traceability matrix that links forward to architecture and test cases — the chain FDA and notified bodies trace during audits.
"IEC 62304 audits fail on the same issues every time: missing SOUP documentation, no traceability from requirements to tests, and safety class determination that doesn't hold up under questioning. These templates close those gaps structurally."
"The SRS template with built-in traceability matrix saved us from a complete documentation rebuild before our notified body audit. Having the architecture template map directly to IEC 62304 Clause 5.3 meant the auditor could follow our structure immediately."
FAQ
Which software safety class applies to my device?
Software safety class depends on the severity of POSSIBLE HARM if the software fails: Class A (no injury possible), Class B (non-serious injury possible), Class C (death or serious injury possible). The classification worksheet walks through the analysis with worked examples.
What is SOUP and why does it matter?
SOUP (Software of Unknown Provenance) is pre-existing software incorporated into your medical device software without adequate development records. IEC 62304 requires specific documentation for SOUP including version identification, published anomaly lists, and functional requirements. Most software uses open-source SOUP.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use in your software development file.
Ready to get started?
6 templates. Instant access. Built for IEC 62304 compliance.
For informational purposes only. Not legal or regulatory advice. Legal