How to overcome regulatory hurdles and launch your SaMD to market faster

Join us for a Software as a Medical Device discussion focused on how to get your SaMD in the hands of real users faster, while meeting regulatory requirements.

Hosted by your friends at [Rangle.io](https://rangle.io/).

In this session, you'll have the chance to hear from Danielle Dorfman Faruq, Regulatory & Quality Director at Kintsugi. 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.

Network with other innovators and entrepreneurs, and listen to industry leaders share how they’ve built and launched digital products in highly regulated markets.

Schedule:
11-11:40 AM - Brief introductions and we'll hear from Danielle
11:40-12 PM - Q and A
12-12:30 PM - Networking

Speaker:
Danielle Dorfman Faruq, Regulatory & Quality Director at Kintsugi

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

P.S. If you can't join us live, a recording of the session will be available after the event on our YouTube channel.