IEC 62304 Revisions and Scope expansion update

IEC SC 62A has agreed that the 2nd edition of 62304 will be expanded to cover all Health Software, not just medical devices. In the interim, an amendment will be issued to clarify current safety classification as well as application of 62304 for legacy software (this was originally intended to be done as part of the 2nd Edition) for medical devices.

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

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