Technical Files & Design Dossiers

CE marking generally requires a company to compile and maintain a Technical File or Design Dossier for the product. Although it contains elements of the Design History File and Device Master Record required by the FDA for U.S. product distribution, Technical Files and Design Dossiers have significant differences and additional requirements, as compared with a DHF and DMR. Design Dossiers require approval by your ISO registrar prior to market introduction, while Technical Files are subject only to post-market review during your routine ISO registrar audits.

AlvaMed’s experienced regulatory consultants can help you demonstrate that your products meet CE marking requirements.  Our staff can verify the classification of your device, help you with the selection of a conformity assessment process, verify compliance to all applicable Essential Requirements, assess your Quality System, and create or review your Technical File or Design Dossier.

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