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Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast powered by Greenlight Guru

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Is There a Systemic Issue With Cappa?

The FDA cites three or there's certainly multiple multiple complaints, which would apply to me probably definitely more than one probably more than two. That says that almost says there's a systemic issue happening here with this product. The other extreme is like it almost never or using cappa system at all. Only 3 to five percent of adverse events of medical devices are actually reported to the manufacturer or to the FDA and I can provide reference to that.

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