EU MDR Compliant Templates for a Multinational Pharmaceutical Company
PMS Support Including Execution and Documentation of PMCF Surveys for a Global Medical Device Manufacturer
Project Summary
Long-term partnership between Celegence and a leading manufacturer of esthetic surgery devices for support with PMS and Clinical Evaluation documentation for complying with regulatory requirements of multiple countries/regions across the globe. The scope of work includes support with planning and execution of Health Care Professional (HCP) Survey-based Post-Market Clinical Follow-up activities.
Celegence Solution & Approach:
Celegence supports the manufacturer by performing the following activities:
Highlights:
Maintenance updates of CEP/CER/LSR for their product portfolio
Creating/Updating PMS Plan
Creating/Updating PMS Reports for EU MDR and other countries/regions
Creating/updating SOPs, Work Instructions, templates
Supporting PMCF activities:
Project Achievements
Celegence team worked closely with the customer’s Regulatory, Clinical, PMS, and Marketing team to gather data points relevant to scope of work.
No observations from EU Notified Body and TGA audits on PMS Reports created by Celegence
Successful execution of HCP-based PMCF Surveys
Project Success
Key to success of this partnership was an experienced team working in tandem with the manufacturer’s cross-functional team and adapting to their processes and requirements to successfully execute the project.
Get in touch today
to discuss your EU MDR needs by reaching out to info@celegence.com or contact us online.
Learn MoreOther Related Articles
24 Dec, 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