Tag: technical file

CE marking

2020-05-27

Technical Documentation for CE marking

This article provides a brief overview of what a technical file is and what it should contain. Special attention will be given to the contents of the technical documentation for respiratory products (e.g. face masks) according to the PPE Regulation 2016/425.

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CB Scheme ce check ce marking ce marking documentation ce marking process clever compliance compliance compliance documentation compliance officers declaration of conformity expert consultation FCC FDA GAP analysis IVDR MDR medical devices ppe 2016/425 product certification product certification mark product compliance hub product compliance management product design phase product markings Risk classification scip scip notification scip requirements supplier compliance management technical documentation technical file time management useful tools