EU MDR compliance support for a Global Medical Device Manufacturer​

Project Summary

A global medical device manufacturer partnered with Celegence for medical writing services to create and maintain clinical evaluation and post-market surveillance (PMS) documentation. The project was delivered through a hybrid model combining a Functional Service Provider (FSP) approach and a Center of Excellence (CoE) framework. Celegence leveraged its proprietary CAPTIS® Platform for literature search, document authoring, and collaboration with over 60 Key Opinion Leaders (KOLs). An Information Coordination (IC) team was established to facilitate smooth data collection from the client’s systems and ensure efficient communication between writing teams and KOLs.

Highlights:

Creation and maintenance of Clinical Evaluation Plans and Reports (CEP/CER) for MDR compliance

Development of PMCF Plans and Evaluation Reports (PMCFP/PMCFER) to support post-market clinical evidence

Preparation of PMS Plans and Reports (PMSP/PMSR) ensuring continuous device performance monitoring

Compilation of Periodic Safety Update Reports (PSURs) summarizing ongoing safety and performance data

Delivering 200+ documents covering 45+ products across three global business units

Coordinating with 6–8 KOLs from Medical Affairs, Engineering, Regulatory, PMS, Risk, and Marketing for each document

Ensuring alignment and consistency of information across all deliverables