What's the gap between CE-marking and FDA's approval?

[Fahle]

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?

Best regards,
Fahle

 

[Kevin Mader]

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.

Regards,

Kevin