Clinical Evaluation Plan and Report of a Radiological Imaging Software
Regulatory Submission Support for Catherter and Guidewire
Project Summary
A combination product manufacturer partnered with Celegence for regulatory submission support for two key devices: a Catheter and a Guidewire. Celegence led strategic planning, documentation drafting, and project coordination, including preparation of the MDR eCTD file for the Catheter and conducting an MDR gap assessment for the Guidewire. The team worked closely with third-party suppliers and the notified body (Kiwa Belgelendirme Hizmetleri A.Ş.), ensuring strong submission readiness for both product lines.
Scope of Work
Preparing MDR-compliant eCTD components for the Catheter
Drafting dossier sections and creating a structured submission plan
Coordinating with third-party suppliers for master file integration
Conducting an MDR gap assessment for the Guidewire
Guiding the client through submission requirements and NB discussions
Managing project governance through regular client and supplier meetings
Project Achievements
Submission-ready MDR documentation for the Catheter
Clear MDR gap assessment for the Guidewire
Strengthened coordination with suppliers and stakeholders
Improved submission preparedness through strategic regulatory support
Project Success
Success was driven by Celegence’s coordinated project governance, cross-functional expertise, and proactive communication with the client, suppliers, and the notified body—ensuring clarity, alignment, and timely progress toward MDR submissions..
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Celegence provides regulatory consulting, documentation preparation, and submission planning to help manufacturers move efficiently toward MDR compliance. 📧 Email: info@celegence.com
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05 Dec, 2025
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