How do you prepare Clinical Evaluation Reports (CERs) without spending months reviewing clinical literature?
In this case study, MadeAi partnered with a medical device manufacturer to conduct systematic literature reviews supporting Clinical Evaluation Reports (CERs) for three vascular devices. Using AI-assisted search, explainable screening, structured data extraction, and SME validation, the team generated submission-ready clinical evidence aligned with EU MDR and MEDDEV requirements.
Across three projects, the platform reviewed 919, 265, and 132 publications, completing the reviews in just 2–4 weeks with up to 94% AI screening accuracy. AI-assisted screening, automated evidence extraction, and expert validation enabled the delivery of CER-ready literature summaries and evidence tables with complete traceability.
See how AI-assisted literature review helped accelerate CER evidence generation while maintaining the quality, transparency, and compliance required for regulatory submissions.
