To receive a CE marking of your medical device, the notified bodies have to be able to evaluate, whether your device is safe and can fulfil the intended purpose. For this scientifically substantiated, reliable and solid clinical data are needed. It may be sufficient to use only literature based clinical data and experiences of your or a equivalent device for the clinical evaluation. In this respect it has to be kept in mind, that PMCF studies have to be conducted for medical device, which initial conformity assessment procedure was solely based on reference devices.
If the quantity or quality of literature based clinical data is not sufficient for a approval, you need a clinical investigation of your device to gain substantiated clinical data. The aim of the clinical investigation is to confirm safety and performance of your device used in its intended purpose and assess the nature and extent of associated risks.
- Prove CE conformity and therefore be approved for the whole EEA
- Extend the intended purpose
- Assessment and verification of the safety and performance of your medical device
- Gain first practical experience
The complete study management for medical devices of all risk classes over all project phases. Together with you we develop the clinical investigation plan, conduct the study according to the approved investigation plan and assist you with:
- Elaboration of the technical documentation
- Creation of the EU declaration of conformity
- Establishment of the post market surveillance plan (PMS plan)
- Regular updates of relevant parts of the technical documentation like the periodic safety update report (PSUR) and the EU declaration of conformity
- All offered in our range of services and more