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Extensive and ongoing training in how to use and interpret data is regulated. Furthermore, you may be able to better track the results of these new processes that you are implementing into your organization to see which processes are more effective. The question pertains to approval in Europe, Australia, Japan, Canada and how that relates to a US approval, and secondly, what type of 510(k) to prepare in the US.  Look at my web site;  http://www.webinarjammemberarea.com/