How to Meet FDA, DiGA, and MDR requirements?

The DTx market is predicted to be worth $9 billion by 2025. The rapidly growing DTx niche in digital healthcare sends good signals for humanity: more people will be capable of receiving high-quality healthcare outside clinics.

One of the most vulnerable points of entry to the DTx industry is the rigorous digital therapeutics regulations in different parts of the world that overwhelm aspiring innovators. It’s true that digital therapeutics regulations are constantly evolving and it’s not the easiest sphere to navigate without prior experience.

We created a guidebook for digital healthcare actors that want to enter the DTx field as well as companies with DTx products that want to get a reimbursement and want to learn about:

  • Which DTx products need approval from FDA, DiGA, or MDR?

  • Why should DTx products comply with the regulations?

  • How to become FDA/ DiGA/ MDR approved?

  • What DTx regulations are there in the EU and the US?

  • Why engineer, scale, and expand DTx products with Binariks?

Planning to engineer, scale, or expand your DTx product?

We can help you at every stage of your product journey. We are an experienced tech partner with a proven record of delivering market-ready DTx products. What makes Binariks stand out from the competition? Binariks is on a shortlist of the Top 1000 Global Companies, and an AWS Select Consulting, Google Cloud, and Gold Microsoft Partner with ISO 9001:2015 and ISO/IEC 27001:2013 Certifications.

Our processes and practices are wired around the goal to deliver secure, compliant, scalable, and interoperable solutions. Our multifunctional tech team will help you cover the following functions:

  • DTx product scaling

  • DTx product design

  • DTx compliance consulting

  • DTx product engineering

Contact us to learn more about the successful DTx product delivery cases we’ve covered previously and to book a consultation with our sales representatives.

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