Dr. Sonja Neuhofen, Trainerin RA / QA

Dr. Sonja Neuhofen has been working in the health science and IVD sector since 1999, with a focus on Regulatory Affairs and Quality Management. She has supported numerous IVD development projects, prepared technical documentation, and guided manufacturers through conformity assessment procedures. She also established ISO 13485-compliant QMS for certification.

Since 2016, she has worked as an independent trainer, supporting manufacturers, health institutions, regulatory authorities, and Notified Bodies in navigating EU regulations. Her core expertise lies in the In Vitro Diagnostic Regulation (IVDR 2017/746). She offers in-depth training on regulatory obligations for in-house IVDs, performance evaluation, and technical documentation.

What matters most to her as a speaker:
"I aim to share regulatory knowledge in a practical, engaging, and enthusiastic way. My training courses focus on the participants’ questions and specific needs. Open exchange enhances understanding and facilitates structured implementation of regulatory requirements. My goal is to create shared ‘aha’ moments—with joy in learning."