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View Full Version : Technical File, GHTF's STED and Recommended Content of 510(k) Comparison/Relationship temujin 10th March 2008, 06:25 AM Hi, Does anyone have a comparison chart for the european "Tecnical File", GHTF´s STED and the recommended content of a 510(k)? regards t. harry 10th March 2008, 08:15 AM As far as I know, we don't have a comparison chart here but there's a recent discussion which is quite closely related: Technical Documentation, DMR, ISO 13485 vs. FDA, STED (http://elsmar.com/Forums/showthread.php?t=26200) It's also found in the 'similar discussions thread' box below after the retitling by Marc. |
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