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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. If I were to ask you, "Who is the buyer of your medical devices. This means that you must be ready to embrace a new model for your business that prepares your organization for the challenges ahead.  Also visit my weblog ...  http://www.longtailprosoftware.org/