Some of our products critical to the medical device are outsourced through the distribution chain. When discussing the Quality Agreement, do we ask for one from the distributor or the actual manufacturer?
We sent one of the agreements to the distributor, and he answered (and, frankly, had a point) that since he is not a manufacturer, this is not a binding document, applicable to his relationship with us.
How to deal with distributor vs manufacturer quality agreements? Who shall provide us with the quality agreement?