Software in Medical Devices, a blog by MD101 Consulting

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Updates to good old IEC 62304

Georg Heidenreich, one of the author of the Frequently Asked Questions on IEC 62304 published on the Team NB website, posted two weeks ago an article about the upcoming updates in the first amendment of IEC 62304.

The article is here: Updates to good old IEC 62304 !.

The amendment 1 of IEC 62304 is expected in the second semester of 2015. Thus the changes described in Georg's post will be helpful to anticipate the harmonization in EU and recognition in the US of this amendement.

Enjoy!



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