Is Design Transfer to Production be complete prior to Release of first production lot

E

ElmerF

#1
Hi Everyone,

I have a question regarding Design Control and commercialization. My understanding is that Design Transfer to production must be completed prior to releasing first lot of product (assume any necessary approvals are in place). It is part of Design Control. There is some pressure to release the product following Design Validation review and prior to DTTP and a colleague is citing a prominent medical device company that apparently did this in the past. I can find nothing to support this but other than the Design Control process flow diagram which shows release to market following design transfer to production I cannot find wording that clearly shows this to be required. Does anyone have any additional guidance on this?

? 820.30(h) Design transfer.​
?​
Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.


While this doesn't overtly say that you can't release product it is implied by the fact that this is the process whereby "the device design is correctly translated into production specifications." is approved.

Thanks for any comments,

Best regards,

ElmerF
 
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Marcelo

Inactive Registered Visitor
#2
Re: Is Design Transfer to Production be complete prior to Release of first production

You need to finish design transfer (including any validation and things like that) before you can release the product.
 
E

ElmerF

#3
Re: Is Design Transfer to Production be complete prior to Release of first production

Thanks Marcello!
 
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