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In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents. I start up at the International level (IEC & ISO)
1 January 2019 is not far away and the 4th edition of the standard may have a significant impact on the design, testing and documentation of many medical devices that have not met this standard yet. For the US (FDA),
Update of May 5 2017 Addition of the Published Documents “EU MDR & IVDR were Published in OJEU TODAY Friday May 5, 2017″ Stop the Presses and add these earth shattering Regulations to your reading list for the next week or