Post-Market Surveillance

As a manufacturer of medical devices you are obliged by the Medical Devices Act to implement a proper monitoring systems (post-market surveillance, PMS) as part of your quality management system.

Dr. Notghi Contract Research GmbH supports you in the routine implementation of the various post-market surveillance activities, to verify the long-term safety and performance of your medical device and evaluate them.

We can assist with:

  • the implementation of a vigilance system
  • the reporting of incidents
  • the collection and analysis of safety information in the databases of the competent authorities
  • the evaluation of the annual customer feedback
  • the literature research of clinical and biological data
  • the planning and implementation of post-market clinical follow-up studies (PMCF)

Our experts will gladly advice you personally. We look forward to your call or your message.