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

Background – Client Needs:

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.

Project Initiation & Key Objectives:

Update the previous MDD CER to comply with the requirements of the EU MDR 2017/745.

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.

Project Outcomes & Achievements

The medical writing team saved a substantial number of effort hours in literature retrieval and screening, reducing costs and resource burden significantly.

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