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Learning Level: Advanced
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Ines Labugger, PhD (she/her/hers)

Product Expert IVD
TÜV SÜD

Dr. Ines Labugger, PhD, is a Senior Product Specialist (SPS) for In Vitro Diagnostic (IVD) Devices at TÜV SÜD and Global Training Coordinator for Technical Documentation (TD). She has more than 20 years of experience in the IVD field, including extensive time in industry and the past six years at a leading Notified Body, TÜV SÜD. Her expertise combines strong scientific and technical knowledge with in-depth understanding of regulatory and quality management requirements under the IVDR. Ines holds a PhD in Immunology and brings seven years of academic and practical experience in blood transfusion medicine.
Before joining TÜV SÜD, Ines held senior positions at Alere Inc. and Abbott Rapid Diagnostics in Research & Development and Product Lifecycle Management. She led cross-functional teams developing innovative diagnostic solutions for infectious diseases and supporting their regulatory clearance. She also oversaw global technical support for the product portfolio and managed international clinical performance studies in Europe, Africa, and Latin America.
At TÜV SÜD, Ines combines her manufacturer-side experience with notified body expertise in her role as Subject Matter and Technical Specialist. She maintains and advances state-of-the-art knowledge for IVD devices, providing global technical and regulatory guidance. As Global Training Coordinator for Technical Documentation, she is responsible for the development, delivery, and continuous improvement of authorization-relevant training programs, ensuring harmonized competence and excellence across international assessment teams.
Beyond internal training initiatives, Ines actively contributes to external manufacturer trainings in collaboration with the Team Notified Body and regularly participates in TÜV SÜD’s manufacturer-focused Digital Dialogue sessions, sharing practical insights into building robust, compliant technical documentation under IVDR.

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