How do you prepare a Clinical Evaluation Report (CER) without spending months on literature review and evidence synthesis?
In this case study, MadeAi partnered with a medical device regulatory team to conduct a systematic literature review aligned with MDR and MEDDEV requirements. The team searched multiple databases, screened studies, extracted key evidence, and generated structured outputs to support CER development.
Using AI-assisted screening combined with SME validation, MadeAi reviewed 2,532 records, achieved 93% accuracy, and delivered a submission-ready evidence package in just 3 weeks, helping accelerate regulatory readiness while maintaining quality, traceability, and compliance.
See how AI-assisted screening, SME validation, and submission-ready evidence generation came together to support faster, compliant CER development.
