Applicability
Development and maintenance of software that is a medical device or an embedded or integral part of a medical device.
What Changed
No new regulatory change is claimed; this entry identifies the current IEC source page and scope statement.
What Did Not Change
The IEC source states that the standard does not cover validation and final release of the medical device.
Practical Impact
Separate product-software lifecycle evidence from validation of production or quality-system software and from final device validation.
Actions to Consider
Confirm product classification, jurisdictional recognition, applicable edition, and the organization’s approved lifecycle procedures.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.