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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. "yet another knee implant", or do you want them thinking "reproducible surgical technique" or "happy patients, returning to their normal, active lifestyle. Don't get hung up on the "edifice complex"--many outstanding agencies have very modest offices.  my page -  http://www.easysketchprodownload.org/