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.
