Enhancing Efficiency in Clinical Evaluation Reports (CERs)

In the EU, securing approval for medical devices requires the preparation of a Clinical Evaluation Report (CER), which is a critical component for obtaining the CE marking needed to market these devices. The process is both intricate and time-intensive, demanding a thorough analysis of clinical data. Additionally, collecting post-market surveillance information and adverse event reports from databases like FDA MAUDE, TGA Australia, and Health Canada poses significant challenges. Discover how CS Life Sciences revolutionized adverse events analysis within their CER process, achieving a 93% time reduction and enhanced accuracy through the implementation of Basil Systems' advanced AI tools.



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