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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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