REGULATORY AFFAIRS


ADAX can support you in all activities related to achieving Regulatory compliance for your Medical Device and to obtain the CE marking:

  • Classification of the medical device and entry of the device into the register
  • Auditor of ISO 13485 Quality Management System for Medical Devices
  • EC Declaration of Conformity
  • Instructions for use and labels of the medical device
  • Medical device technical File
  • Activities of the Authorized Representative of manufacturer
  • Vigilance system and Post-Market Surveillance
  • Clinical Evaluations
  • Clinical Investigations
  • Periodic Summary Report (PSR)