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Posts by Michael May

Michael May
Oct 2
in Quality, Regulatory | 14 comments

How ISO 13485:2016 section 7 changes impact your QMS

There is no question whether ISO 13485:2016 section 7 changes will impact your Quality Management System (QMS). In my previous blog I stated that the two major themes in changes to the ISO 13485 standard are taking a risk based approach and documenting everything. They are also two of the core differences in section 7, […]

Michael May
Aug 3
in Quality, Regulatory | 14 comments

How ISO 13485:2016 changes will impact your QMS (sections 4-6)

With the March 1, 2016 release of ISO 13485:2016, medical device developers and manufacturers have been given a three year grace period to implement changes from the previous 2003 version. During those three years both the 2016 and 2003 versions will be valid to operate under; however after the three year grace period, compliance with […]

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