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Design Transfer from R&D to Manufacturing for 21 CFR 820

T

terry31575

#1
I am looking for a check list of all that must be captured in a design transfer from R&D to manufacturing. Is there a generic list out there that I could then add to for our specific product?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I am looking for a check list of all that must be captured in a design transfer from R&D to manufacturing. Is there a generic list out there that I could then add to for our specific product?
Hi,

Basically, the design transfer activity is intended to ensure that the DMR is complete and adequate. I believe you will find what you're looking for here (a little bit of fun reading ;)):

http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122576.htm

Cheers,
Ronen.
 

indubioush

Quite Involved in Discussions
#5
So many different ways to do this. You could have a plan and record if you are transferring to a contract manufacturer. Or, your transfer record could be the change order(s) in which the product changes status. You could have a product development phase review in which the DMR is reviewed as complete and approved for production. You can have all of the above. Normally, transfer activities occur over time. It is not a one time event. What kind of transfer activities do you do now? Chances are you already meet the requirements at least partially.
 
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