CAPTIS™: MDD to MDR CER Remediation of a Standalone Software

Project Summary

Manufacturer of a standalone software used for imaging and visualization of cardiac anatomical structures is working with Celegence for clinical evaluation of their software medical device.

Celegence Solution & Approach:

The previous MDD literature review of 500+ articles was conducted on CAPTIS. The new, extended date range for the MDR CER resulted in 950+ articles and overlapped with the date range of the previous MDD CER. Using CAPTIS’s project cloning and search editing features, Celegence’s medical writers could leverage previous screening decisions for all repeating articles, cutting down the overall literature screening time by almost half.

Highlights: