IEC 62304 checklist
The key life-cycle deliverables and activities for medical device software, in one place. Use it to plan your documentation and to sanity-check coverage before a review.
Key deliverables and activities
Scale the depth of each item to your software safety classification.
- Software development plan defining the processes, deliverables, and life-cycle model
- Software safety classification (Class A, B, or C) for the system and its items
- Software requirements specification, traceable to system requirements and risk controls
- Software architectural design describing the software items and their interfaces
- Detailed design for software items where the safety class requires it
- Implementation with unit verification
- Integration and integration testing records
- Software system testing against the software requirements
- Software release record, including known anomalies and their evaluation
- Risk management activities and records, integrated with ISO 14971
- Configuration management, including version control and change control
- Problem resolution process and records for defects and change requests
- Traceability across requirements, architecture, implementation, and verification
Common questions
What does this IEC 62304 checklist cover?
It lists the key life-cycle deliverables and activities the standard expects, from planning and requirements through design, verification, release, and the supporting processes of risk management, configuration management, and problem resolution.
Does the checklist depend on my software safety class?
Partly. The higher the safety class, the more detail the standard expects, particularly around detailed design and verification. The checklist covers the full set; scale the depth to your classification.
How can Traceable help me work through it?
Traceable provides templates for these documents and keeps requirements, architecture, and verification traceable as they change, so the traceability item at the bottom of the list stays satisfied instead of drifting.
Keep the traceability item satisfied
See requirements, architecture, and verification traced in one place.