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This is how medical devices are regulated. The FDA doesn't micro manage or guide your development. They just say "you must have a quality management system spel
by digler999 10y ago
This is how medical devices are regulated. The FDA doesn't micro manage or guide your development. They just say "you must have a quality management system spelled out and stick to it. However it's written you must obey it. "
- coredog64 10y agoThere's a little more to it. There's some CFR standards that you must adhere to (it's been 12 years, so I don't recall the CFR part number off the top of my head).