HomeAgendaSpeakers

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

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.
Read more

About me

Social media

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