When You’re in Regulatory, Everything Looks Like a Device: Managing the Complexities of a Mixed Software Portfolio

• 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

Speakers:

Prerana Gurubasavaraj

Manager, Regulatory Product Strategy & Delivery

ResMed