Birgit Wahlmüller
Senior Expert Quality Management
MADx (MacroArray Diagnostics GmbH)
Vienna, Austria
5 profile visitsSpeakerSpeaker
Experienced QM/RA expert (ISO 13485, IVDR) dedicated to practical QMS, team alignment, and ensuring top quality standards in the medical device industry.
My organisation
MADx (MacroArray Diagnostics GmbH)
MADx (MacroArray Diagnostics GmbH)
Small and medium-sized enterprise
Vienna, Austria
MADx – Macro Array Diagnostics is a science-driven company redefining immunodiagnostics with future-oriented, all-in-one solutions based on molecular technology. Our innovative platforms support comprehensive diagnostics of IgE-mediated allergies and IgG-mediated food intolerances, offering the world’s most extensive molecular allergen panel—178 allergens on a single array. This unique approach delivers unmatched specificity and reliability, setting a new gold standard for allergy testing.
Speaker sessions (2)
Wednesday, 15 October 2025
11:00 - 12:15
A1: Softwaretools for supporting regulatory affairs
Location:Room 1: Maria Theresia
Moderator: Martin Schmid
13:15 - 14:30
B2: Session on regulatory aspects around IVDs
Location:Room 5: Franz Joseph
- Ingrid Blaimaumer: Manufacturers & Notified Bodies: Overcoming IVD Certification Hurdles
- Christian Schweiger: Best practice on in-house IVDs: process and examples
- Birgit Wahlmüller: IVDR in Practice: Challenges of Sampling, Changing Reviewers and Lessons Learned