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Helin Räägel

Helin Räägel

Senior 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 medical device manufacturers and global regulatory bodies on a daily basis. Thanks to her distinguished academic background with over ten years of experience in scientific research, she has a broad knowledge of biological systems and the analytical procedures used to evaluate biocompatibility in vitro and in vivo. She also has over two years of medical device experience managing validation work for regulatory acceptance and is a member of several ISO 10993 work committees.

Dr. Räägel received her PhD in molecular cell biology, with research focusing on cell migration, polarity, and targeted delivery of bioactive therapeutics. Her postdoctoral research project aimed at discovering the molecular mechanisms behind organ development and structural assembly using in vitro techniques and animal models. Her successful academic career was rewarded by an Alexander von Humboldt Fellowship in Germany, and later by a Marie Curie Fellowship, distinctions competitive on a global scale. Since that time, her experience has been wide-ranging including leadership and involvement in a variety of special projects relevant to biocompatibility of medical devices and their materials.