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I understand that there is FDA regulation on the device some how. Is the device built under GMP?

April 26, 2017built device fda GMP regulation understand

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I understand that there is FDA regulation on the device some how. Is the device built under GMP?

1 Answer

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I need to check on this matter. We have a 510k on the sensor and we are subject to fda inspections of course, but I am not sure if technically we claim gmp compliance. I need to check with our Qa people.