Helin Räägel, Ph.D.
Helin Räägel, Ph.D.
Biocompatibility Expert
Nelson Laboratories
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 U.S. FDA and EU regulatory bodies as the primary audience. She works closely with medical device manufacturers and global regulatory bodies on a daily basis. She has a broad knowledge of biological systems and the analytical procedures used to evaluate biocompatibility in vitro and in vivo. She is also an active member of ISO and ASTM working groups related to biological safety evaluations.

Dr. Räägel received her Ph.D. in molecular cell biology, with research focusing on cell migration, polarity and targeted delivery of bioactive therapeutics. 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.