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View Full Version : How does the USFDA treat compilers? (software use in medical devices) altair123 13th May 2005, 04:04 AM Has anybody here had experience submitting a 510(k) for a medical device with software? Did the USFDA require validation of the compiler and other software development tools? Pataha 13th May 2005, 05:59 PM http://www.fda.gov/cdrh/comp/guidance/938.html#_Toc517237928 also do a search on this forum, I have ran across good information altair123 17th May 2005, 01:49 AM Thank you very much for the link |
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