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EN ISO 14971 – Risk Management: ALERT

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Tuesday, 07 May 2013
Risk Management 1 Comment

risk_womanThe revised EN ISO standard is effective now – it is past the “grace period!” Risk Management has now become a serious business!  Please do not take it lightly; The time is now!  

The EN ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices was published in July, 2012 and became effective on 10/30/2012 … simultaneously as the preceding 2007-2009 standard was discontinued.  This was a rather brief notice to allow those in the industry to get prepared.  Wonder if this is a preview of things to come … who knows?

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