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MedTech Summit

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10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

Heike Möhlig-Zuttermeister
Director Expertise Management & Segment Manager IVD at TÜV SÜD
Speaker

Profile

Heike is leading the IVD team at TÜV Süd since December 2022. Before joining TÜV Süd Heike spent 8 years at BSI managing a global team of technical experts and 1,5 years at a global medical device consulting firm RQM+ to drive and further strengthens the IVD regulatory strategy at RQM+.

Heike’ s background is a PhD in Molecular Immunology, and she obtains ~20 years’ scientific & regulatory experience in different leadership roles in life technology & IVD industry and at two leading IVDR Notified Bodies, BSI & TÜV Süd. In her position at TÜV Süd she is responsible for the regulatory oversight for all IVDD & IVDR products and the respective conformity assessment work as well as for developing and maintaining the competence for the IVD technical team.

Heike is driven to establish and maintain an agile and practical approach to serve the patient management in the EU by delivering compliant, time sensitive and collaborative conformity assessments to achieve a timely EU market success for IVD devices.

Agenda Sessions

  • Multi-Stakeholder Discussion: Certifying Companion Diagnostics (CDx)

    14:45
  • Shared Experiences: Leveraging Data from Previous Submissions

    11:10