IDMP Data Readiness for a Mid-Sized Pharmaceutical Company
EU MDR compliance support for Tissue Perfusion Imaging Device
Project Summary
A medical device manufacturer developing a tissue perfusion imaging device partnered with Celegence for MDR-compliant documentation to support initial CE marking. The engagement covered drafting Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up (PMCF) Plans, and SOPs for PMS and PMCF. Leveraging Celegence’s proprietary CAPTIS® Platform, the project streamlined literature searches, data evaluation, and collaboration with subject matter experts.
Project Deliverables
Author CEPs and CERs in accordance with the EU MDR and MDCG guidelines for initial CE-Marking
Address Notified Body observations within stringent timelines
Author SOPs for CEP, CER, PMS, and PMCF that align with general PMS requirements from other regulatory bodies, such as Health Canada, in addition to the EU MDR
Perform systematic literature searches and article appraisals, and develop State-of-the-Art reports to evaluate current technologies and establish safety and performance benchmarks from similar devices and validated bibliographies
Maintain high-quality standards through multi-level internal reviews and QA processes
Assess requirement of PMCF activities and drafting PMCF survey questionnaire
Project Achievements
Successfully remediated CEP and CER to address NB observations
Worked closely with the client’s team to draft the responses to the NB observations and appropriately update the CEP and CER
The project was completed within the stringent timelines for re-submission to the Notified Body
Appreciation from the client for the support provided by Celegence and for adapting to their requirements
Project Success
Close collaboration between Celegence’s adaptable medical writers and the client’s experts was central to success. The team’s regulatory knowledge, process adherence, and ability to quickly identify and resolve documentation gaps ensured compliance, efficiency, and client satisfaction.
Need MDR-Compliant Documentation for Innovative Devices?
Celegence delivers CEPs, CERs, PMCF, and PMS strategies powered by CAPTIS® and expert consulting—helping you achieve CE marking success with confidence. 📧 Email us at info@celegence.com
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11 Sep, 2025
25 Aug, 2025
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