Kitty Makra, Director, Digital Strategy
Yena Lee, Strategist
2022-12-01

How to launch your SaMD to market faster

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.

animated doctor
Yena Lee, Strategist
Gustavo Oregel, Principal - Visual & Motion Design
2022-09-26

Motion graphics are an effective way to add visual interest to any website or app. They're also a great way to highlight key points in your content and improve patient compliance. We've put together examples of how motion graphics can be used effectively in digital therapeutics.

Venn diagram overlapping a mobile device
Kitty Makra, Director, Digital Strategy
Yena Lee, Strategist
2022-09-20

Last week at our second SaMD meetup, we discussed how to apply agile product management strategies to building and validating digital therapeutics.

a web connecting people with healthcare and technology
Yena Lee, Strategist
Kitty Makra, Director, Digital Strategy
2022-09-09

At Rangle, we’re creating a community for innovators in the software as a medical device (SaMD) space.

roadmap through a stethoscope around a mobile phone
Yena Lee, Strategist
2022-08-22

A core component of a premarket submission is clinical evidence. Clinical evidence is gathered through a process of clinical validation, which involves gathering data on the safety and effectiveness of the product. The overarching goal of clinical validation is to demonstrate to regulators that the device will work, as intended, for target users.

SaMD by Rangle
Kitty Makra, Director, Digital Strategy
Yena Lee, Strategist
2022-08-02

At our first meetup, we explored the what and whys of Software as a Medical Device.

Medical implements  and SaMD iconography on mobile device
Yena Lee, Strategist
Kitty Makra, Director, Digital Strategy
2022-06-21

Software as a medical device (SaMD) represents an opportunity to successfully build and launch patient-centric digital health products and platforms. In this article, we'll take you through the fundamentals: what is (and isn't) a SaMD, how federal and international agencies classify and regulate SaMD, and how you can get your digital health product to market faster.

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