Technical Documentation and Design Dossier

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Medical device manufacturers have to provide a Technical Documentation (Tech-File) for every medical device.

For class III products a more complex Technical Documentation - a Design Dossier is required.

A Technical Documentation contains amongst other documents:

Product description
Product design description/ product layout
Confirmation documents to prove compliance with the Essential Requirements of the MDD
Risk analysis
Clinical evaluation
Labeling

Prosystem supports you during the identification of the required documents and verification certificates for Tech-Files or Design Dossiers and compiles the required documentation.

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