Prerana Gurubasavaraj
Manager, Regulatory Product Strategy & Delivery ResMed
Seminars
Thursday 23rd July 2026
When You’re in Regulatory, Everything Looks Like a Device: Managing the Complexities of a Mixed Software Portfolio
11:30 am
- Categorizing software as a medical device (SaMD) versus non-medical device functions
- Understanding new regulations in the digital health space, including EU MDR perspective
- Navigating the AI/ML space, including algorithm-only submissions and clearances
