AI & Regulatory Evolution in Healthcare: Bridging Innovation and Compliance

Topic
  • Key Presentations & Panel Discussion: 4:30-6:00 PM (PST) (onsite and Zoom)

   Gain valuable insights on wide-ranging, cutting-edge topics:

○ Artificial Intelligence/Machine Learning (AI/ML) in healthcare.

○ Software as a Medical Device (SaMD): Regulatory Pathways.

○ FDA and EU MDR compliance.

○ Implications of the New FDA Rules on Quality Management Systems

   Regulation (QMSR) and Laboratory Developed Tests (LDTs).

○ From the Frontlines of Healthcare AI: Clinic Perspective

  • Round Table Panel Discussion: Engage with our distinguished panel of thought leaders and regulatory experts.

Presenters

Don Lin
Don Lin, PhD
Co-founder, Chief Innovation Officer, and Director of Quality Assurance & Regulatory Affairs, Telesair, Inc.
Helen Chow
Don Lin, PhD
Senior AI RAQA Specialist, Mayo Clinic, Center for Digital Health, AI Enablement
Yu Zhao

Yu Zhao

Founder and President of Bridging Consulting LLC

Amnon Talmor
Amnon Talmor
Senior Principal Regulatory Affairs Specialist at Medtronic


When

Jan 18 2025 (Saturday)

4:00-7:00 PM (PDT) onsite

4:30-6:00 PM (PDT) Zoom


Where

Zoom meeting and

Irvine water district conference room, 15600 Sand Canyon Ave, Irvine, CA 92618


Free Registration

registration link for onsite  (Free parking and light refreshment)

registration link for Zoom


Questions

Website: http://www.sabpa-ocla.org

Email: Sabpa.ocla@gmail.com