Day

May 25, 2015
The International Medical Device Regulators Forum (IMDRF) SaMD draft of a quality system for Software as a Medical Device is available for public comment.
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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...
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“Being Agile & Compliant”

2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019

Come meet John F. Murray, Jr., who recently retired from FDA and joined SoftwareCPR®, at the course!

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