Christiana 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.
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.
She is a certified auditor for ISO 13485 (TÜV SÜD) and QMB (TÜV SÜD).
Christiana’s main focus and experience 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.
“I am very passionate about Combination products because it is a perfect match for me as I can combine my passion for biomedicine, toxicology, and my experience in medical devices that I gained over the past years.”
Hobbies: Gravel biking Tennis, SUP, Theatre, crime thriller
Expertise
- Injection devices (autoinjectors, Pen system)
- Infusion systems
- Dialysis
- Toxicology
- Biocompatibility
- Art 117 MDR - Notified Body Opinion (single, integral combination products)
- Disinfectant