Current Edition Checked October 24, 2026
Edition 1.1 is current. A second edition is at committee-draft stage; a final draft is not expected before 2028, and the draft cannot be used for a conformity claim.
Next: Edition 2 would widen the scope to health software and simplify safety classes; plan for it, but build to 1.1.
What It Covers
The life cycle processes for software that is part of a medical device or is itself a device: development, maintenance, risk management, configuration management, and problem resolution.
Who It Applies To
Manufacturers of devices containing software and of software as a medical device, and their software suppliers.
Key Requirements
- A software safety class (A, B, or C) assigned from risk, which sets how much rigor each activity needs.
- A software development plan, requirements, architecture, and for higher classes detailed design and unit verification.
- Software of unknown provenance (SOUP) identified, with its requirements and known anomalies evaluated.
- A maintenance plan, problem resolution, and configuration management after release.
What an Auditor Asks to See
- The software development plan and the safety classification rationale.
- The SOUP list with versions and evaluated anomalies.
- Traceability from requirements to tests, and the problem reports since release.
Where Systems Fall Short
- SOUP lists missing operating systems, libraries, or their versions.
- No defined process for evaluating problem reports after release.
How QES Helps
Software files aligned to the device risk file, with SOUP and problem resolution brought under document control.
Related Standards
Sources. IntuitionLabs — IEC 62304 Edition 2 status (updated October 2026) (opens in a new tab); IEC Webstore — IEC 62304 (opens in a new tab). Status checked October 24, 2026. This page summarizes IEC 62304; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.