Vigilance system setup

Setup of product vigilance system


  • establish your product vigilance system, including relevant SOPs, contractual and data exchange agreements with suppliers and service providers to assure your compliance with regulatory requirements and setup/maintain vigilance plans for your product (e.g. PSMF)
  • prepare / maintain your product risk management plan or risk-benefit profile
  • establish dedicated and validated safety database for the product
  • register your company and your product with national and international competent authorities and databases (e.g. EV, EUDAMED, DIMDI, etc.)
  • train all parties involved in your product vigilance  system