New Release! BS EN ISO 14971:2012

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BS EN ISO 14971:2012, Medical Device Risk Management, was released July 6, 2012.  This revision changes only the EN version and not the ISO version.   With regards to the EN version, more informative references have been added between the standard and the medical device directive (MDD 93/42/EEC).  Some of these changes may present a challenge to medical device manufacturer’s that … Read More