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.