Getting innovative devices approved in today’s regulatory landscape

About this session

- Exploring options when traditional clinical data requirements cannot be fully met at submission
- Establishing a robust clinical strategy using early dialogue, risk-based justification and post-market commitments
- Leveraging expert panels, NB consultations and scientific advice to de-risk approval pathways
Moderator: Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

Speakers

• 

  Jens Pfannkuche

  Director Regulatory Affairs · Penumbra

  Panelist

• 

  Manuela Stauss-Grabo

  Senior Vice President and Head of Clinical Research · Fresenius Medical Care

  Panelist

• 

  Fatima Bennai-Sanfourche

  Senior Director of QA & RA Compliance for Medical Devices and eHealth · Bayer

  Moderator