Topics / Standards and assurance
IEC 62304 evidence should stay connected to the software change.
Medical-device software lifecycle records are easier to review when requirements, risk-related behavior, implementation and verification share an identifiable basis.
Respect the boundary of the standard.
IEC’s published scope for IEC 62304:2006 with Amendment 1:2015 covers development and maintenance of medical-device software. It explicitly excludes validation and final release of the medical device itself.
Source: IEC: IEC 62304 consolidated edition. Scope and edition reviewed 3 October 2026.
Confirm the applicable edition and project obligations with the responsible quality and regulatory team. Completing a software evidence record is not equivalent to validating or clearing a device.
Follow a change through its evidence.
Illustrative example
A unit conversion changes a displayed value.
A refactor changes the conversion used by a display. The record should identify the approved units, rounding behavior, input range and handling of unavailable data. Verification should inspect the relevant outputs and failure conditions on the changed build. This is a software illustration, not a clinical claim.
- Record the intended behavior and the authority behind it.
- Connect the change to risk-related requirements and affected interfaces.
- Retain current verification and unresolved anomalies.
- Identify the product versions to which the conclusion applies.
Use Proof for a bounded evidence workflow.
Proof connects requirements, hazards, code and verification records. That structure can reduce repeated reconciliation when engineers and assurance reviewers examine the same change.
Start with one existing workflow and compare the record with what the quality team actually needs. Any missing lifecycle, independence or device-level evidence remains a separate obligation; a generated report must keep those limits visible.
Try it on your software
Review one medical-device software change with your quality team.
Bring the applicable plan and a change whose evidence is costly to assemble.