Technical FilePreparation for Medical Devices - I3CGLOBAL
I3CGLOBAL medical writing services prepare the documentation required by regulatory agencies in the approval process for medical devices. These regulatory documents require solid scientific and technical expertise to summarize the necessary data collected in the course of developing a medical device . A CE marking technical file or a design file ( Class III ) is a comprehensive description of your device intended to demonstrate compliance with European requirements. The compilation of your technical file or design dossier is a critical step in Europe's CE marking approval process and a requirement for compliance with the Medical Products Directive 93/42 / CEE and the new MDR Medical Products Regulation 2017/745. Your technical file or dossier includes detailed information on the design, function, composition, use, declarations, and clinical evaluation of your medical device. A technical file is required for all classes of products (Class I, IIa, IIb, and III)