Our experience means that we are able to help you to comply with the regulatory and normative requirements imposed by the various notified bodies

Our offerings

stage1 :BRINGING MEDICAL DEVICES TO MARKET

  • Analysis of the normative and regulatory context of your developing projects
  • Creation of CE marking applications (Dir 93.42.CEE & MDR 2017/745, Dir 98.79.CE & MDR 2017/746) / 510K / other export applications
  • FR/EU reimbursement application

stage2 :KEEPING MEDICAL DEVICES ON THE MARKET

  • Renewal of CE marking / CE/510k modification application

  • Updating of DHFs / Product Files

  • Creation of specific documents: Clinical evaluation report (MEDDEV 2.7.1 Rev4)

  • Post-Marketing Surveillance Report, Critical Analysis Report (ANVISA), etc.

     

stage3 :REGULATORY AFFAIRS STRATEGY

Introduction of new regulatory strategies:

  • Change of notified body
  • Introduction of the UDI
  • Specific justification for questions / non-compliance issues raised with regards to your body
a few facts and figures
115 CE RENEWALS ISSUED
32 INITIAL CE MARKINGS OBTAINED
198 CERTIFICATION/VALIDATION OF EQUIPMENT
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