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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!
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!