Advice on setting up BD Distribution Deals - How much oversight is required?

A

aa759

#1
I work for an organization that is just begining to enter into distribution deals with other organizations. We are looking to distribute class III medical devices. Right now we are operating as if these suppliers are Implant OEMs. Realistically they are not OEMs. We are strictly distributing product for another company. They have a product that we want to offer our surgeons. Where are the Quality/Regulatroy requirements for my company (the distributor) defined? It seems to me that since the ownership of the QS and design reside at the manufacturer that their compliance risk is actually our business risk. Having said that, we should just determine the amount of Quality risk we think is acceptable and audit the potential supplier to that standard. Ultimately the only trouble for my organization is the fact that we have told our surgeons we are bringing widget X to the table and suddenly we do not have widget X bc the manufacturer is in FDA trouble.

My organization is very risk adverse with supplier controls which is why we are being so stringent now. I would love it if we could completely understand the FDA's required level of oversight so that we could tailor our procedures accordingly.

I am looking for feedback on how other organizations handle distribution deals and suggestions about where I can find more information published by the FDA on the issue. I have googled searched a variety of topics and I am just not finding what I need. Maybe I am looking in the wrong place or searching for the wrong things??

Thanks in advance for your help!

-QM in need
 
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#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 
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