Software as a Medical Device
Foundations
Learn more about SaMD and how it will change the future of healthcare.
What is Software as a Medical Device? A guide to building products & platforms at the speed of tech, not healthcare
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.
Launch New ProductsHow 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.
Ship AI Features
How to succeed in the digital therapeutics space: An agile product management approach
Last week at our second SaMD meetup, we discussed how to apply agile product management strategies to building and validating digital therapeutics.
Launch New Products
World's first Javascript React Native app with CE marking as a class II SaMD
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Frontend Development
Frontend Development
Modernize customer-facing systems with frontend architectures that are easier to evolve.
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New Product Development
Product Development
Launch new products with a traction-first approach to discovery, delivery, and growth.
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A cutting-edge digital therapeutics app built in just a few short months
We re-designed and improved the user flow for a digital therapeutics app in a few months.
Case Study
Ipsen
Rebuilding the native Dysport dosing guide to a Progressive Web Application in 5 months
We rebuilt Ipsen's native Dysport dosing guide to a Progressive Web Application with Vue.js in 5 months.
Case Study
Synaptive
A neurosurgical medical device interface built in just 24 weeks
Improving surgical team communication and patient outcomes.
Case Study