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We Achieved ISO Certification! Now What?

Global Medical Device Podcast powered by Greenlight Guru

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Does Your CAPA Program Need a CAPA?

A lot of companies look at this is where we are. We have three or four defects per thousand. And they're waiting for it to get worse so they can do the CA part. Whereas, you don't let your QMS drive you forward. You know, if 3 or 4 parts per million or per thousand, whatever it is, is that's good enough? That's for you right now. But in those cases where you don't perceive a gap, there's two ways to create a gap. It's either based on the data is suggesting it, you know, we're not performing where we want to be. Or there's a strategic way to create the gap, which

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