Dr. Alexandra Deters is a toxicologist with certified expertise according to Section 47 of the German Infection Protection Act (IfSG).
She is responsible for preparing expert reports and assessments on the infection risk associated with medical devices that are manufactured from or contain materials of biological origin (zoonotic risk). In addition, she evaluates the biological hazard and biological risk of medical devices in accordance with applicable regulatory requirements.
As a trainer, Dr. Deters provides training through the qtec Academy for medical device manufacturers, pharmaceutical companies, regulatory authorities, and notified bodies, focusing on zoonotic risk assessment and biological safety.
What matters most to her as a speaker: “Requirements for zoonotic risk assessment and biological safety of medical devices have significantly increased in recent years. As a biologist, I guide our seminar participants in minimizing—or even eliminating—the risk of infectious disease transmission through their products and in developing and implementing an optimal testing strategy to demonstrate biological safety.”
