A medical engineer with 15 years of experience in medical devices and combination products, Stephanie is an expert in drug-device combinations. She has joined from TUV SUD, where she was a product specialist on Article 117 (MDR) and a member of the respective Team NB (European Association of Notified Bodies) working group. Stephanie leads clients in their transition to the MDR through regulatory analysis, readiness audits/checks, and personalized training.