Medical Device Packaging - Trying to learn Technical files

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dragmytoe

Good day all, This is my "go-to" site when I am stumped, since I'm just learning the Regulatory side to Medical Device...Hopefully this is a simple question.
My company is creating packaging that will not only hold our device (orthodontics) but can be used by the dr. to sort the product.....so my question...do we need a technical file and design history for this type of product. I believe it falls into the Class I non-medical catagory..
Thanks for your help!:thanx:
 

Marc

Fully vaccinated are you?
Leader
Would you be so kind as to share with us here what you came up with? We'd all appreciate it very much!
 
D

dragmytoe

Oh sure!! Sorry.
Since the packaging in itself is not a medical device, it does not require a Technical File.
As good practice, we are going thru and abbreviated version of Design Review. (minus risk analysis, etc)
 
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