At our third Software as a Medical Device meetup, Danielle Dorfman Faruq (Regulatory & Quality Director at Kintsugi) shared learnings and tips on how to get your SaMD in the hands of real users faster, while meeting regulatory requirements.

Danielle led Apple’s Digital Mental Health Study and the development, testing, and deliverables for de novo submissions of Apple’s first FDA-regulated features on the Apple Watch. Now, she’s on a mission with Kintsugi to make mental healthcare access available for everyone, with a novel AI-based digital health product to detect signs of depression and anxiety from speech.

Key Takeaways:

• Strategies to get your product into the hands of real users in the US
• Clinically validate and launch digital products in highly regulated markets
• Insider’s tips and learnings from developing, testing, and getting FDA clearances for digital health products

Hope to see you at our next SaMD meetup!