Saudi Food & Drug Authority (SFDA) compliance support for Laboratory Management Software Manufacturer
EU MDR compliance support for Dental Products Manufacturer
Project Summary
Medical writing and consulting services for creation and maintenance of the following regulatory documents in compliance to EU MDR:
- Clinical Evaluation Plans (CEPs),
- Clinical Evaluation Reports (CERs),
- Post Market Surveillance (PMS) Plan & Report, Periodic Safety Update Report (PSUR)
- Post Market Clinical Follow-up (PMCF) Plan & Report
- Summary of Safety and Clinical Performance (SSCP)
- Post Market Clinical Follow-up (PMCF) Clinical Evaluation Protocol.
The project is structured as a Center of Excellence (CoE). Celegence uses their proprietary CAPTIS® Platform to search for literature, write, review, and maintain 100+ documents.
Highlights:
Author CEP, CER, PMS Plan, PMSR, PSUR, PMCF Plan/Report, and SSCP in compliance to EU/MDR 2017/745
Assess adequacy of clinical data based on Product history, Pre-clinical and Clinical studies, Complaints, AEs, Literature, from Notified body perspective
Designed and developed PMCF survey protocols compliant with EU MDR requirements
Perform systematic literature searches, article appraisals, and developed validated bibliographies
Project Achievements
>98% quality & timeline delivery performance despite stringent timelines, an achievement in collaborating with Celegence expertise
Enhanced compliance outcomes through expert guidance from team
Faster turnaround and minimal review comments due to strong process adherence and clear understanding of regulatory requirements
Project Success
Key to success of this partnership is a dedicated and highly adaptable team capable of managing the shifting priorities while maintaining quality standards. Efficient project management and tracking were also the key to the success of the partnership, ensuring consistent on-time delivery.
Need MDR-Compliant Documentation for Dental Products?
Celegence delivers CEPs, CERs, PMS, PMCF, PSUR, and SSCP with high quality and >98% on-time performance—powered by CAPTIS® and expert regulatory teams. Email us at info@celegence.com
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08 Aug, 2025
10 Jul, 2025
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