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What does the MDR tell us about Post-Market Surveillance?
Learn more about the role of Post-Market Surveillance during the lifecycle of your device, the specific requirements for PMS under the MDR, and how an EDC system can help you fulfil these requirements in a cost-effective way.
Three expected changes to the FDA medical device approval process in 2019
At the end of 2018, the FDA announced several upcoming changes to the way medical devices are approved in the United States. In this white paper, we will discuss three expected changes to the FDA medical device approval process in 2019.
The in-vitro diagnostics regulation (IVDR): From oversight to overhead
This white paper will focus on the new in-vitro diagnostics (IVDR) and discuss the key changes for IVD companies.
Find out how castor can help you with MDR & Post Market Surveillance requirements
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