Fresenius Kabi Contract Manufacturing

In this Connect to Frankfurt session, Philipp Annecke, Junior Key Account Manager and Heinrich Martens, VP Regulatory Affairs of Fresenius Kabi (Bad Homburg, Germany) present guidances from the Medical Devices Regulation on clinical data evaluation for medical devices, and how manufacturers can select the right method and strategy for collecting post-market clinical follow-up data (PMCF) 

The MDR (Medical Device Regulation) requires a detailed evaluation of the clinical data for a Medical Device. It is important that the manufacturers are using the right method and strategy for collecting those PMCF data. PMCF should be linked and part of the PMS and Clinical process. Using the “right” software tool does support an effective collection of the data. It also allows that the manufactures can easily and fast work with the received information for further processing and evaluation. Giving the end-user a “friendly” interface and quick access, does support the process and supports a smooth and good communication with the different stakeholders.
PMS process and the integrated PMCF information What are PMCF information Case study on collection PMCF information. Choose the right statistic How to work with the customers and stakeholders in a software tool, regarding PMCF data Case study and further evaluation with collected PMCF information / data

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