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PMS Support Including Execution and Documentation of PMCF Surveys for a Global Medical Device Manufacturer

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:

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Maintenance updates of CEP/CER/LSR for their product portfolio

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Creating/Updating PMS Plan

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Creating/Updating PMS Reports for EU MDR and other countries/regions

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Creating/updating SOPs, Work Instructions, templates

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Supporting PMCF activities:

Project Achievements

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Celegence team worked closely with the customer’s Regulatory, Clinical, PMS, and Marketing team to gather data points relevant to scope of work.

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No observations from EU Notified Body and TGA audits on PMS Reports created by Celegence

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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.

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