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), but no two technical files are the same because the type of product dictates the information that is included in it. 

 

Your technical file must be reviewed by a notified body (unless you manufacture a class I product) that is not supplied sterile and does not have a measurement function.

 

Knowing how to collect this information and submit it for review by Notified Bodies is essential. We can help you in this process:

 

  • Review all existing documentation in support of compliance with the applicable Essential Requirements / GSPR.
  • Clinical Evaluation and identify gaps or deficiencies in your documentation.
  • Compile your EU Technical File or Design Dossier, with internal peer review.
  • Determine the requirements and testing standards applicable to your product.
  • Review your clinical data, compile a Clinical Evaluation Report (CER), and provide a risk assessment if necessary.
  • Review your labeling proposal and instructions for use.

 

 

 

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