Strategic Regulatory Consulting for Ancillary Medicinal Substances and Clinical Evidence
EU MDR compliance support for a Gastrointestinal Reflux Monitoring Device Manufacturer
Project Summary
Medical writing and consulting services for the creation of EU MDR-compliant Literature Search Protocols (LSPs) and Literature Search Reports (LSRs) to support Class IIa gastrointestinal reflux monitoring medical devices.
Celegence leveraged their proprietary CAPTIS® Platform to perform literature searches, review clinical data, and author regulatory documentation in alignment with MDR requirements.
Highlights:
Developed EU MDR-compliant LSPs and LSRs using structured methodologies including literature framework and defined eligibility criteria
Extracted, reviewed, and assessed clinical data for relevance, quality, and regulatory applicability
Provided regulatory consulting to align all documentation in compliance with EU MDR and support integration with broader clinical evaluation processes
Project Achievements
Celegence collaborated closely with manufacturer’s regulatory and clinical teams to develop EU MDR compliant documents
All documentation was aligned with regulatory requirements and internal quality standards
The project was completed within tight deadlines, enabling timely regulatory submissions
The collaboration ensured smooth communication and efficient delivery of project milestones
Project Success
Key to success of this partnership is the technology-driven processes, expert collaboration, and seamless information flow to ensure efficiency, quality, and compliance..
Need MDR-Compliant Documentation for Gastrointestinal Devices?
Celegence delivers EU MDR-compliant LSPs, LSRs, and clinical evaluation support—powered by CAPTIS® and expert collaboration—to ensure timely submissions. Email us at info@celegence.com
Learn MoreOther Related Articles
25 Aug, 2025
08 Aug, 2025
Contact Us Today
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
"*" indicates required fields