Christiana Hofmann, PhD Anteris Medical

Christiana Hofmann is a medical device and combination product senior professional with more than 10 years experience in the Medtech and Pharma industry. She worked for both mid size and global manufacturers but one of the largest Notified Body TÜV SÜD, where she was responsible for Combination Products in her last role. From her educational background she is a biologist with holding a Phd in Toxicology. Over the years she gained profound expertise in auditing QMS / MDD / MDR, assessing technical documentation incl. biocompatibility of a wide range of class IIa products. Her main focus and experience is as SME is Art 117 MDR. Within TÜV she was overall responsible for implementing and improving the NBOp assessment process within TÜV SÜD for the DACH & Nordics region. She is a recognized conference speaker for drug device combination products, biocompatibility and EU medical device regulation. “She is very passionate about combination products because it is a perfect match for her as she can combine her passion for biomedicine, toxicology, and her experience in medical devices that she gained over the past years.”