How do you prepare Periodic Safety Update Reports (PSURs) without spending months manually reviewing clinical literature and safety evidence?
In this case study, MadeAi partnered with a medical device manufacturer to conduct a systematic literature review supporting PSUR requirements. Using AI-assisted screening, expert validation, and structured evidence extraction, the team streamlined the review process and generated submission-ready outputs.
Within just 2 weeks, the project reviewed 187 records, achieved 89% AI screening accuracy, and delivered PSUR-ready evidence tables and summaries with complete citation traceability.
See how AI and human expertise worked together to accelerate regulatory evidence generation.
