62304 Amendment Status May 2015

The ballot on the final draft of the IEC 62304 amendment, which focuses on safety classification and legacy software, closes in May. We expect publication by July, followed by a consolidated version that incorporates the amendment. Adoption by CENELEC as an EN is happening concurrently, so harmonization by the EU should happen late this year or early next year.

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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