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How to design an Instruction For Use and validations for EU and US

Published Date: March 1, 2024

In this free on-demand webinar, Kathleen Peymen, PhD, Senior Expert, takes you on an road trip to discover ‘How to design healthcare processing instructions and validations for EU and US.’

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Navigating the landscape of healthcare processing validations can be challenging. Different countries around the world have different healthcare practices, but also different regulatory expectations. Much like taking a road trip there is no right or wrong way to turn, it all depends on what you want to see along the way. In this webinar, we will help you map out your road trip for designing processing instructions and validations and provide guidance on where to take a different turn based on whether your target market is EU, US or both.

This webinar was recorded at Nelson Labs Europe – Leuven, Belgium.

Katleen Peymen, PhD Study Director Healthcare reprocessing and Microbiology

Katleen Peymen, PhD

Senior Expert

Katleen Peymen received her PhD in Biochemistry and Biotechnology from the Faculty of Science at the University of Leuven (Belgium) in 2019. After her career as a post-doctoral researcher, she started at Nelson Labs Europe in 2020 as a Study Director for Healthcare reprocessing and Microbiology. She is responsible for the study design, analysis and reporting of healthcare reprocessing validations for reusable medical devices, such as cleaning, disinfection, and steam sterilization validations, and is an active member of several International Organization for Standardization (ISO) committees related to healthcare reprocessing.

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