Dispositifs médicaux

REGULATORY AFFAIRS

Technical Dossiers and CE marking

  • Determination and justification of the product status
  • Assistance for the classification of the medical device
  • Advice for the choice of the conformity assessment procedure
  • Identification of the applicable standards and regulatory requirements
  • Writing and/or update of the technical file according to Regulation 2017/745
  • Assistance for the writing of specific documents (biological evaluation report, clinical evaluation dossier, risk management file...)
  • Support for the submission of the dossier to the notified body
  • Answers to questions from notified bodies

Specific dossier: Combination products

  • Assistance to determine the status of the product (MD or drug)
  • Writing of specific related documentation
  • Assistance for the submission to the Competent Authorities/Notified Bodies

Advertising

  • Regulatory review of promotional material (whether or not submitted to ANSM for prior authorization, various types of material, including websites) according to the French Regulation
  • Submission to ANSM for prior authorization
  • Assistance for the implementation of a review process and the writing of procedures

Project management

  • Identification, management and coordination of subcontractors by dedicated project manager
  • Monitoring of the process progress - reporting

Environment

  • Definition of your responsibilities as manufacturer for your MDs
  • Assistance for the declaration

Quality system

With our partner

  • Support for the implementation of the quality system according to ISO 13485 standard
  • Preparation of the certification audit by the notified body and inspections by competent authorities

Market Access

With our partner