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Medical Devices Post-marketing surveillance
Medical Devices Post-marketing surveillance
Post-marketing surveillance
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Even after your commercial launch, we can assist you in meeting post-marketing surveillance (PMS) requirements. PMS studies are becoming increasingly important, especially since the latest MDD amendment, as many medical devices have been re-assigned to a higher risk category. However, these studies necessitate a different approach in logistics and setup as well as ongoing efforts on data collection than pre-registration trials. Therefore, we have a dedicated PMS department at MEDIDATA enabling rapid setup and cost-efficient management of such studies. MEDIDATA provides services for paper based, EDC-based, or hybrid (paper CRF + EDC) PMS studies. As a standard, MEDIDATA sets up and maintains reporting websites. These put web-based information at sponsors’ fingertips, e.g. by instantaneous display of recruitment status and the progress of other, defined activities over the course of a study. |
- Medidata GmbH
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- Max-Stromeyer-Str. 166
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- D-78467 Konstanz
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- T +49 (0) 7531.9423800
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- info@medidata.de
