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Hi,
We are the OEM for Class I and Class IIa devices. A few of our customers have requested Private Labeling and that we perform the packaging and labeling of their devices at our facility. (The devices will be sold on the market under their name, not ours.)
When I read 7.2.2, it appears that I should not accept an order from a customer for a Private Labeled product until after we have come to an agreement on the packaging and labeling of that product.
Am I interpreting this too literally?
I had a pretty heart-pounding discussion about this the other day and if I am wrong I'd like to repair the damage quickly.
Can you share with me how you meet this requirement in similar situations?
We are the OEM for Class I and Class IIa devices. A few of our customers have requested Private Labeling and that we perform the packaging and labeling of their devices at our facility. (The devices will be sold on the market under their name, not ours.)
When I read 7.2.2, it appears that I should not accept an order from a customer for a Private Labeled product until after we have come to an agreement on the packaging and labeling of that product.
Am I interpreting this too literally?
I had a pretty heart-pounding discussion about this the other day and if I am wrong I'd like to repair the damage quickly.
Can you share with me how you meet this requirement in similar situations?