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Sonja Hirte, PhD

Clinical Evaluation Manager
Heraeus Medical GmbH

Dr. Sonja Hirte is a clinical evaluation manager at Heraeus Medical GmbH with a strong scientific background and an extensive experience in regulatory documentation for medical devices. Her core expertise lies in the preparation and strategic development of clinical evaluations in accordance with EU Regulation 2017/745 (MDR), particularly in the field of orthopedic surgery.
Over the past years, she has contributed to clinical evaluation both in industry and consultancy roles. At PRO-LIANCE GLOBAL SOLUTIONS GmbH, she supported manufacturers with regulatory strategies and authored clinical evaluations for a wide range of devices. Currently, she leads clinical documentation processes at Heraeus Medical for high-risk orthopedic products and ensures regulatory compliance across international markets.
Her approach combines scientific rigor with practical regulatory insight, shaped by her academic background and previous roles in strategic medical technology and medical device investment planning at Hannover Medical School. She holds a PhD in Molecular Genetics from Hannover Medical School, conducted in cooperation with the QIMR Berghofer Medical Research Institute in Brisbane, Australia.
Dr. Hirte is passionate about translating clinical data into meaningful regulatory narratives and supporting innovation through robust evaluation frameworks.

Presentation(s):