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Maintaining Clinical Evaluation Reports (CERs) has become one of the most resource-intensive challenges for medical device manufacturers operating under EU MDR. As portfolios expand and renewal cycles tighten, manufacturers are expected to demonstrate continuous clinical evidence maintenance – not just periodic CER updates.
Manual CER maintenance, including literature surveillance, document comparisons, and portfolio alignment, places significant operational strain on regulatory and clinical teams. These repetitive activities consume valuable expert time and increase the risk of inconsistencies across CER versions.
This webinar demonstrates how AI-driven automation enables a more efficient and sustainable CER maintenance approach. You’ll see how CAPTIS®, Celegence’s AI-powered regulatory compliance platform, supports :
This approach allows manufacturers to reduce operational burden while improving regulatory confidence and long-term compliance readiness.
In this on-demand webinar, Celegence experts demonstrate how AI-enabled automation helps regulatory and clinical teams improve efficiency, strengthen documentation consistency, and support audit readiness across device portfolios.
Online Webinar
March 12, 2025 | 10:00 AM ET
During this webinar, our experts cover practical strategies and real-world applications, including :
Associate Director – Medical Device Services
Dr. Pratibha specializes in clinical evaluation and regulatory strategy for medical devices, including complex and software-based devices. She has supported manufacturers in achieving MDR compliance and addressing Notified Body observations across multiple therapeutic areas.
Manager – Medical Device Services
Rohan has over nine years of experience supporting CER development and regulatory compliance for medical device manufacturers. His expertise includes CER authoring, PMS and PMCF integration, and helping teams maintain audit-ready clinical documentation.
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