Based in Grand Est (France), Ms. Guthmann is a certified Quality and Regulatory Affairs consultant with over 20 years of experience in the medical device and in vitro diagnostic industries. She is also a qualified auditor for ISO 13485 and conducts certification audits on behalf of two Notified Bodies. Prior to founding SEVE Conformity, she held senior QA/RA management positions at Bio-Rad, Biosynex, Novartis and ForeNAP Pharma. Her key achievements include multiple ISO 13485 certifications, CE marking of IVD devices, and successful ANSM inspections.

Ms. Guthmann holds a Master's degree in Project Management (2002) and a University Diploma in Regulatory Affairs for Medical Devices (2023). She is also Green Belt certified and trained in ISO 13485 auditing.

The value she brings: accelerating market access, avoiding audit findings, building efficient and compliant QMS, and offering expert support without losing project control. As a certified Notified Body auditor with 20 years of experience, she helps medical device companies in Eastern France decode and apply CE marking and ISO 13485 requirements—with a pragmatic, empowering, and results-driven approach through SEVE Conformity