On January 11, 2016 the publication of the third edition of the standard ISO 13485:2016 was approved by the Technical Committee ISO TC/210.

The official publication is expected by the end of March 2016, then a three year transition period will follow.

To support the implementation of the standard, the Technical Committee has proposed to draw up a new guidance instead of the up-to-date of ISO 14696.

For further information:http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752

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