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intr
Joined: 22 Sep 2013
Posts: 5
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 Posted: Sun Sep 22, 2013 6:43 pm Post subject: Quality |
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You'll be able to respond to patients' needs and improve quality
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hendershotcarol104
Joined: 24 Sep 2013
Posts: 10
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| Posted: Tue Sep 24, 2013 11:09 am Post subject: |
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The Food and Drug Administration (FDA) has established CFR Part 820 - Quality System Regulation (QSR), also known as 21 CFR 820 or "current Good Manufacturing Practice" (cGMP). This regulation applies to medical device manufacturers or importers of devices intended for "human use". Compliance with this regulation is expected from any organization that manufactures or imports such devices into the USA.
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