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Category " ISO 13485"





 New ISO 13485 Medical Device Standard

Date: 28 Sep 2016
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ISO 13485 Standards was updated on 1st March 2016. With the ongoing reviewing and updating of all the Management Standards, it is interesting to note that ISO 13485 is the exception. In particular ISO 13485 follows the previous Standard (and ISO 9001: 2008) Index layout. This is in-spite of ISO specifying that all new or revised Management Standards in 2013 will comply to the new Annex SL format...


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