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jdy11
The medical device that our company manufactures will now be a Class III for CE marking purposes and we will need to create Design Dossiers for these products -- we currently have Technical Files for them as they were Class II devices.
Would someone explain the difference between a Technical File and a Design Dossier? Does anyone have a nice template or table of contents that I could use as guidance?
Thanks for your help!
Would someone explain the difference between a Technical File and a Design Dossier? Does anyone have a nice template or table of contents that I could use as guidance?
Thanks for your help!
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