Dispositifs médicaux

Regulatory strategy

  • 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

CE marking

  • Writing and/or update of the technical file
  • Preparation of the dossier for a modification or renewal of the medical device registration
  • Ensuring the availability of specific documents (biological evaluation, clinical evaluation, risk management file...)
  • Support for the submission of the dossier to the notified body
  • Answers to questions from notified bodies

Specific dossier - Combined MD

  • Audit and preparation of the technical file
  • Advice on CTD format and content of the quality part
  • Writing of the quality documentation for the ancillary medicinal substance

Project management

  • Identification and coordination of subcontractors
  • Monitoring of the process progress - reporting
  • Review and validation of the documents

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
STRATÉGIE SANTÉ
19, rue Georges Clemenceau
78000 Versailles - France
Tél. +33 (0)1 42 86 86 00
contact@strategiesante.com