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Old 6th August 2004, 12:47 PM
Fahle Fahle is offline
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Please Help! What's the gap between CE-marking and FDA's approval?
I wonder about the differences between the MDD’s CE-mark and FDA approval. If a company is certified with ISO-9000 and their product is CE-marked, what is needed to do in order to ensure QSR compliance?

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Old 6th August 2004, 01:34 PM
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Hej Fahle,

The biggest difference to me is that FDA gives approval to market products after a detailed, comprehensive review of verification and validation of the design.

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