Comparison between Iso 14385 and Iso 15378

(Nguyễn Duy Thái) #1

Hi all
Here are some issues I misunderstood.
Iso 15378 is about primary pakaging materials for medical products
Iso 14385 is about medical device including catridge, syringe, etc.
So is manufacturers with Iso 14385 higher in quality management than that with Iso 15378 ?
And if they have Iso 14385 certificate, do they still need for Iso 15378 certificate?
Thanks all