PMCF expertise published in Journal of Medical Device Regulation
High quality PMCF surveys under the EU MDR – from planning through to execution and data analysis
Published in the JMDR February 2025 Issue
Authors: Marcus Torr, Chris Webb, Martha Vakalopoulou-Paschalidou, Lily Pitter, Jorn van Binsbergen and Amber Majoor
Download the article to gain integral PMCF insights, including:
Understand all applicable stages in the process of creating and executing high quality PMCF surveys, often illustrated with practical examples
Identify the elements required within a PMCF survey, with specific emphasis on how to link clinical claims to measurable outcome parameters and acceptance criteria;
Understand that the questionnaire design is the critical factor in ensuring accurate and measurable data are collected
Learn how a proper methodology for execution of a PMCF survey is set out, including survey programming and validation, data collection and data management
Study some examples of final data analysis, alongside guidance on what to do should the data collected not be as anticipated and unable to meet the acceptance criteria
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Purdie Pascoe PMCF survey expertise
Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with ISO requirements and GDPR regulations, for PMCF surveys. We can support you with the design, implementation, data collection and reporting of your PMCF surveys to ensure you collect appropriate PMCF data to be used within your MDR submissions.