CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
EU MDR compliance support for a Global Medical Device Manufacturer
Project Summary
Medical writing services for creation and maintenance of clinical evaluation and post market surveillance (PMS) documentation. The project is structured as a hybrid delivery model, with a combination of Functional Service Provider (FSP) & Center of Excellence (CoE). Celegence uses our proprietary CAPTIS® Platform to search for literature, write, review, and maintain the documents, and collaborate with 60+ Key Opinion Leaders (KOLs). An Information Coordination (IC) team was established for gathering relevant information from the customer’s document management systems, and smooth coordination between the medical writing teams and the KOLs.
Project Deliverables
Creation and maintenance of clinical and PMS documents - Clinical Evaluation Plans and Reports (CEP/CER), Post Market Clinical Follow-up Plans and Reports (PMCFP/PMCFER), PMS Plans and Reports (PMSP/PMSR) and Periodic Safety Update Report (PSUR).
200+ deliverables for 45+ products across manufacturer’s 3 separate Global Business Units.
Coordination with 6-8 KOLs from Medical Affairs, Engineering, Regulatory, PMS, Risk, and Marketing, on each document.
Alignment of information across all documents.
Celegence Solution & Approach:
Highlights:
Project Achievements
Scalability and flexibility in resource allocation with consistent and best practices.
Easier review by, and collaboration with, the KOLs on CAPTIS®.
IC team to ensure timely, organized access to critical inputs and minimize delays and miscommunication.
Continuous improvement and feedback loops for quality improvement and operational efficiency.
Project Success
Key to success of this partnership is the hybrid delivery model, technology-driven processes, expert collaboration, and seamless information flow to ensure efficiency, quality, and compliance..
Ready to Scale Your EU MDR Compliance Efforts?
Leverage our hybrid FSP & CoE delivery model and the CAPTIS® platform to streamline your clinical evaluation and PMS documentation. Email info@celegence.com
Learn MoreOther Related Articles
25 Mar, 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