Date: 4 June 2024
Time: 15:00 – 17:00 CEST
Location: Virtual
Price € 395,-
Introduction
PMCF user surveys are questionnaires to end-users of a medical device that are designed to collect clinical data. To be able to use those data to support that you have sufficient clinical data under the Medical Device Regulation (MDR), a high-quality survey is required. Such a survey is patient-specific and well-designed, with clearly stated endpoints, a statistical analysis plan and appropriate rationale for the design, among other requirements. In this training we will examine in detail how a survey can be designed, conducted, and reported, including definition of endpoints and statistical considerations.
Audience
Professionals in the medical device industry, in particular in regulatory and clinical roles, who want to understand how PMCF user surveys can be deployed to collect clinical data in compliance with the MDR.
Learning objectives
- Learn how PMCF user surveys can be used to collect clinical data for regulatory purposes
- Learn how to design, conduct and report a high quality PMCF user survey
- Learn about the practical considerations when designing, conducting and reporting a PMCF user survey
- Understand the limitations of surveys as a PMCF activity