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Project Summary
Celegence provides specialized medical writing services to support regulatory compliance for medical device manufacturers. To enhance the efficiency and accuracy of clinical documentation, Celegence leveraged its proprietary CAPTIS® platform for literature, writing, reviewing, and maintaining documents. The client required comprehensive clinical and post-market surveillance documentation for a Class II medical device with limited available clinical data. This posed a significant challenge in meeting regulatory expectations for evidence-based evaluations.
Highlights:
Clinical Evaluation Plans (CEP)
Clinical Evaluation Reports (CER)
Post-Market Clinical Follow-up Plans (PMCFP)
Post-Market Clinical Follow-up Reports (PMCFR)
Project Achievements
Successfully created and maintained CEP, CER, PMCFP, and PMCFER documents despite limited clinical data, through expert-driven narrative development and risk-benefit justification.
Develop robust justifications for data limitations while aligning with MDR and MEDDEV 2.7/1 Rev.4 guidance.
Enabled the client to demonstrate ongoing compliance with post-market surveillance requirements.
Project Success
Celegence’s expertise and structured authoring were key to this partnership’s success, ensuring strong alignment with MDR expectations and successful success despite data limitations..
Facing Data Gaps in Your Clinical Documentation?
For Class II devices with limited clinical data, Celegence helps build strong, MDR-aligned narratives and PMCF strategies—supported by CAPTIS® and expert authoring. Email us at info@celegence.com
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10 Jul, 2025
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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.
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