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Technical Dossiers and CE marking

Depending on the conformity evaluation procedures to be followed, obtaining the CE certification always requires manufacturers to prepare a Technical Dossier of the Product and of Quality Management System.

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for MDs and IVDs, and can support manufacturers during the whole process to obtain the CE marking for their medical devices.

The main services offered in this field are:

  • Feasibility studies regarding the CE marking project
  • Support in the transition to Regulation (EU) 2017/745 (MDR): drafting, review, update of the product technical documentation and of the quality system
  • Verification of the conformity of the technical documentation and requirements for the registration of product and manufacturers in Italy, in the EU and in some extra-EU countries (gap analysis)
  • Search for Notified Bodies and assistance in the conformity evaluation process to obtain and maintain the CE marking
  • Search and contacts with qualified laboratories for device testing, and with Contract Research Organizations (CRO) for the relevant clinical trials
  • Drafting/review/update of clinical evaluation plans and reports (CEP and CER)
  • Drafting/review/update of risk management plans and documents
  • Check/review of labels and IFUs/manuals
  • Preparation of the documentation for clinical trials applications to Ethics Committees and Competent Authorities
  • Packaging graphic design

Foto di Aymanejed da Pixabay