How can high-quality PMCF surveys be conducted under the EU MDR? We are excited to share a free article published in the JMDR February 2025 issue, “๐๐ข๐ ๐ก-๐ช๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐๐๐ ๐ฌ๐ฎ๐ซ๐ฏ๐๐ฒ๐ฌ ๐ฎ๐ง๐๐๐ซ ๐ญ๐ก๐ ๐๐ ๐๐๐ โ ๐๐ซ๐จ๐ฆ ๐ฉ๐ฅ๐๐ง๐ง๐ข๐ง๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐ญ๐จ ๐๐ฑ๐๐๐ฎ๐ญ๐ข๐จ๐ง ๐๐ง๐ ๐๐๐ญ๐ ๐๐ง๐๐ฅ๐ฒ๐ฌ๐ข๐ฌ.” The article is written in collaboration with Jorn van Binsbergen, Amber Majoor, Marcus Torr, Chris Webb, Martha Vakalopoulou-Paschalidou, and Lily Pitter.
Jorn van Binsbergen, one of our writers, sums it up best: “A well-structured PMCF survey is not just a compliance exerciseโitโs the key to generating meaningful clinical evidence that truly supports patient safety and product performance.”
Download the article to gain integral PMCF insights, including:
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Understand all applicable stages in the process of creating and executing high-quality PMCF surveys, often illustrated with practical examples;
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Identify the elements required within a PMCF survey, with specific emphasis on how to link clinical claims to measurable outcome parameters and acceptance criteria;
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Understand that the questionnaire design is the critical factor in ensuring accurate and measurable data are collected;
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Learn how a proper methodology for the execution of a PMCF survey is set out, including survey programming and validation, data collection, and data management;
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Study some examples of final data analysis, along with guidance on what to do should the data collected not be as anticipated and unable to meet the acceptance criteria.
Download the article via the link: https://lnkd.in/eZimnhnS.