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:

  • 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:
    • Create/update PMCF Plan
    • Design, initiate, monitor, collect response and close survey, and disburse incentives to respondents
    • Document statistical analysis of data gathered from Survey in the PMCF Analytical Report
    • Document conclusions from PMCF activities, impact on Benefit-Risk Profile and, impact on other parts of the Technical File in the PMCF Evaluation Report

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 Outcomes

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.

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