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IEC 62304 Compliance Checklistfor Medical Device Software
Assess your software against IEC 62304:2006/Amd 1:2015 requirements. Track compliance clause-by-clause, identify gaps, and generate professional reports – completely free.
WHAT’S INCLUDED
Everything You Need For
IEC 62304 Compliance
A structured, clause-by-clause assessment framework –
whether you’re starting fresh or auditing an existing product.
Complete Clause Checklist
All clauses from IEC 62304:2006 with Amendment 1:2015, automatically filtered to your safety classification (A, B, or C) with built-in guidance.
Real-Time Dashboard
Live compliance score with per-clause progress tracking. See where you stand and which areas need the most attention as you work through the assessment.
Gap Analysis Report
Automatically identifies non-compliant and partially compliant clauses, grouped by severity. Ideal for pre-audit preparation and remediation planning.
Professional PDF Reports
Generate branded compliance reports with your company logo, executive summary, gap analysis, and full checklist – ready for regulatory submission.
Device Class Guidance
Start with your EU MDR device class (I, IIa, IIb, III) and the tool suggests the appropriate IEC 62304 software safety class with clear rationale.
Evidence Tracking
Document evidence references, assign responsible persons, and add comments for each clause. Export as CSV or JSON for QMS integration.
UNDERSTANDING THE STANDARD
What Is IEC 62304?
IEC 62304 is the internationally recognised standard for medical device software lifecycle processes – covering development, maintenance, risk management, configuration management, and problem resolution.
Who Needs IEC 62304?
Any manufacturer developing software that is itself a medical device (SaMD) or part of a medical device. The standard is recognised by the FDA, EU MDR Notified Bodies, and regulatory bodies worldwide.
Key Principles
IEC 62304 is risk-based – the level of documentation and verification scales with the potential harm from software failure. Classification into Class A, B, or C determines which clauses apply.
Current Version
IEC 62304:2006 with Amendment 1:2015. Key changes include refined software safety classification, legacy software provisions, and expanded system testing requirements.
| Clause | Process Area |
|---|---|
| 4 | General Requirements |
| 5 | Software Development Process |
| 6 | Software Maintenance Process |
| 7 | Software Risk Management Process |
| 8 | Software Configuration Management |
| 9 | Software Problem Resolution Process |
WHAT’S INCLUDED
IEC 62304 Software Safety
Classification
Classification determines which clauses apply and the level of rigour required – based on the severity of potential harm from software failure.
Class A
No injury possible
Software failure cannot contribute to a hazardous situation. Requires development planning, requirements, system testing, and configuration management.
Class B
Non-serious injury possible
Requires architectural design, integration testing, risk analysis, and SOUP management – in addition to all Class A requirements.
Class C
Death or serious injury possible
Requires the full set of IEC 62304 clauses including detailed design, risk segregation, and the highest level of verification.
KEY CONCEPT
Understanding SOUP in
IEC 62304
SOUP (Software of Unknown Provenance) – open-source libraries, third-party SDKs, legacy code, and COTS software – must be managed as a Class B and C obligation.
IEC 62304 Requires You To:
- Identify all SOUP items (title, version, manufacturer)
- Specify functional and performance requirements for each
- Review published anomaly lists for safety-relevant issues
- Document required hardware and software environment
- Manage SOUP updates throughout the maintenance lifecycle
Common SOUP Examples:
- Operating systems (Linux, RTOS, Windows Embedded)
- Programming language runtimes (.NET, JVM, Python)
- Open-source libraries (OpenSSL, React, TensorFlow)
- Database engines (PostgreSQL, SQLite, MySQL)
- Communication protocols and middleware
Frequently Asked Questions
IEC 62304 is the international standard for medical device software lifecycle processes. Compliance is essential for EU MDR certification, FDA clearance, and market access in most regulated markets worldwide.
While not legally mandatory in all jurisdictions, it is a harmonised standard under EU MDR and an FDA-recognised consensus standard. In practice, Notified Bodies and regulators expect to see compliance evidence.
IEC 62304 covers software lifecycle processes — how you develop and maintain the software. IEC 82304-1 covers product-level safety requirements for standalone health software. Most products need both.
For a Class B SaMD product, establishing compliant processes typically takes 2–4 months with expert guidance. Retrofitting onto legacy software takes longer. Euverify’s team can accelerate this significantly.
Yes. IEC 62304 is process-agnostic — it defines what must be done, not how. Agile works well provided you maintain required documentation, traceability, and verification at each iteration.
The current version is IEC 62304:2006 with Amendment 1:2015 (IEC 62304:2006+A1:2015). A second edition is in development but has not yet been published.
Yes, completely free with no signup required. Your data stays in your browser — nothing is sent to any server. Use it to assess, track, and generate reports as many times as you need.
Need Expert Help with
IEC 62304 Compliance?
Euverify provides end-to-end compliance services for medical
device manufacturers – from gap analysis and documentation
to ongoing regulatory support.