Christa Bachinger-Hauk
Head of Academy and Marketing
en.co.tec Schmid KG - Consulting & Academy for medical devices and IVD
Vienna, Austria
16 profile visitsSpeakerSpeaker
Specialist in marketing and training for medical devices and IVDs, with over 15 years' experience. I am always interested in collaborations and networking!
My organisation
en.co.tec Schmid KG - Consulting & Academy for medical devices and IVD
en.co.tec Schmid KG - Consulting & Academy for medical devices and IVD
Service providers and consultants
Vienna, Austria
At en.co.tec you can expect individual support and customized advice:
Implementation and auditing of quality management systems at manufacturers and suppliers,, Support with regulatory affairs and compliance with all relevant standards and regulations for medical devices,, risk management & many other standards, and, Online-courses and inhouse-trainings on current topics - such as the EU regulations for medical devices & IVDs, digital health, cybersecurity, EU-AI-Act and many more.
About me
Skills
- Marketing
- Sales
- networking
- trainings
- Regulatory Support
- Medical Devices
- IVD
Interests
- New contacts
- MDR
- IVDR
Speaker sessions (3)
Wednesday, 15 October 2025
11:00 - 12:15
A2: Regulatory aspects around trustworthy AI
Location:Room 5: Franz Joseph
- Ali Moshayedi: Compliance and Trust Under The EU AI Act
- Diether Kramer: Mind the Risk: Bringing Clinical Risk Prediction into Compliance.
Moderator: Christa Bachinger
13:15 - 14:30
B2: Session on regulatory aspects around IVDs
Location:Room 5: Franz Joseph
- Ingrid Blaimauer: 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
Moderator: Christa Bachinger
15:15 - 16:30
C2: Post market surveillance and periodic safety update report (PSUR)
Location:Room 5: Franz Joseph
- Volker Sudmann: Looking beyond the horizon – what matters regarding PSUR
- Viktoria Knoflach: Post-Market Surveillance requirements and submission of PSURs for class III / Implantable devices
- Birgit Sebauer: PMS and its requirements in countries beyond Europe
Moderator: Christa Bachinger