The ISO 13485:2016 Transition Journey
Here is a relevant and timely article regarding the status of the transition to ISO 13485:2016. This article, written by Jim Shore, Chair-elect, ASQ Biomedical Division, published in June 2018 edition of MPO (Medical Products Outsourcing), provides the results of a survey conducted of 150 medical device professionals in March of this year. A significant take-away from this survey is the data indicating 44% and 37% of the respondents noting that challenges to reaching their goal is due to insufficient resources and updating procedures, respectfully, is a major reason.
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