RIM System Migration for a Large Global Pharmaceutical Company
Literature Search Report (LSR) Support in Compliance with EU MDR
Project Summary
Celegence provided medical writing services for manufacturers of dental restoratives, consumable products, and gastrointestinal monitoring devices. The engagement focused on creating and maintaining Literature Search and Report (LSR) documentation to ensure compliance with EU MDR requirements. By leveraging its proprietary CAPTIS® platform, Celegence streamlined literature searches, screening, and analysis while maintaining high-quality standards and regulatory alignment.
Scope of Work
Developing a comprehensive literature search strategy across databases, clinical trial registries, and adverse event databases to identify relevant data for devices under evaluation and establish the state of the art
Screening and appraising 1,000+ articles for suitability and inclusion in the systematic literature review
Reviewing and analyzing clinical data to evaluate safety and performance evidence for the devices
Creating an EU MDR-compliant Literature Search Report (LSR) template in alignment with MEDDEV 2.7/1 Rev.04 and IMDRF 2019 guidance
Project Achievements
100% quality and on-time delivery performance despite stringent deadlines
Enhanced compliance through regulatory expert guidance and robust documentation standards
Real-time project visibility for the client, enabling transparent review and collaboration
Project Success
The success of this engagement was driven by Celegence’s expert literature search specialists, therapeutic-area experts, and the use of CAPTIS® for automation and collaboration. CAPTIS® enabled the client to monitor project progress, review screening outputs, and communicate efficiently with Celegence’s team—resulting in streamlined MDR-compliant literature documentation..
Need Support for EU MDR-Compliant Literature Reviews?
Celegence offers end-to-end literature search and reporting support powered by CAPTIS®, ensuring speed, transparency, and MDR compliance for medical device manufacturers. 📧 Email us at info@celegence.com
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18 Nov, 2025
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