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Furthermore, many companies simply don't have the money to make all of the changes and meet all the other demands asked of them in order to bring their product up to meet FDA standards. 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.  My web site ::  http://www.Webinarjammemberarea.com/