May 24, 2024 | By: Helin Räägel and Natascha Arnauts
This whitepaper is a result of a discussion led by the authors as part of Veranex’s Biocompatibility Coffee Break in February 2024. It includes the critical industry questions that arose during the discussion. Download the PDF below.
Learn about the authors.
Biocompatibility Expert
Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with...
Healthcare Reprocessing Expert
Natascha graduated from Hasselt University – Diepenbeek with a master’s degree in Industrial Engineering, Biochemistry. As an expert at Nelson Labs Leuven she is responsible for reprocessing validation studies for reusable medical devices, which includes cleaning, disinfection, and steam sterilization studies. She is also responsible for cytotoxicity testing and specifically failure investigations. Momentarily she is transitioning to become part of the Nelson Labs biocompatibility consulting team, where her experience with reusable medical devices will be a valuable asset. She shares her knowledge by presenting at various Nelson Labs seminars across Europe. In addition to her work at Nelson Labs, she is currently completing her PhD in Environmental Biology.
