Medical Writing Support for Ophthalmological Devices
Comprehensive PMCF Support for Class I, IIa and IIb Legacy Medical Devices
Project Summary
A leading medical device manufacturer partnered with Celegence to support the planning, development, and execution of Post-Market Clinical Follow-up (PMCF) activities for legacy Class I, IIa, and IIb medical devices. The engagement focused on survey-based PMCF activities involving Healthcare Professionals (HCPs) to collect real-world clinical data on device safety, performance, and use. These activities supported ongoing post-market surveillance and compliance with global regulatory expectations.
Scope of Work
PMCF support for Class I, IIa, and IIb legacy devices
Survey-based PMCF activities with HCP engagement
End-to-end PMCF strategy, execution, and reporting
Statistical analysis and integration into PMS documentation
Support for NB observations through targeted PMCF evidence
Project Deliverables
Developing a comprehensive PMCF strategy, including standard compliance activities and structured HCP surveys
Drafting PMCF Clinical Evaluation Protocols and PMCF Plans
Designing, executing, and monitoring survey-based PMCF activities, including targeted questionnaires focused on safety and performance
Managing HCP engagement, including coordination and incentive disbursement
Collecting survey responses and performing statistical analysis for the PMCF Analytical Report
Preparing PMCF Evaluation Reports and recommending updates to technical documentation to address Notified Body (NB) observations
Project Achievements
Comprehensive and structured collection of post-market clinical data aligned with regulatory expectations
Successful execution of HCP-based PMCF surveys
Integration of PMCF findings into broader Post-Market Surveillance (PMS) documentation
Extension of PMCF services across multiple customers
Project Success
The success of this engagement was driven by a proactive PMCF team that worked closely with the client’s Regulatory, Clinical, PMS, and Marketing teams. Seamless integration with existing workflows and clear communication ensured effective execution and high-quality PMCF deliverables.
Need PMCF Support for Legacy Medical Devices?
Celegence delivers end-to-end PMCF services—from strategy and surveys to reporting—helping manufacturers meet regulatory expectations and maintain post-market compliance. 📧 Email us at info@celegence.com
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12 Jan, 2026
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