Solutions
Digital therapeutics and SaMD, without building the backend
When the software is the medical device, the backend is part of it. Prescription apps, digital therapeutics, mental-health programs and dosing calculators all need secure accounts, patient data, clinical logic and a software lifecycle an auditor will accept. Extra Horizon provides that certified backend, so your team can focus on the therapy.
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Software as the device
The app is the product. So is everything behind it.
With no hardware to set it apart, a digital therapeutic depends on its clinical evidence, its user experience and the trust of clinicians and payers — all of which rely on a backend most teams would rather not build.
The whole product falls under IEC 62304
When the software is the medical device, its backend is in scope too: lifecycle documentation, SOUP management and cybersecurity evidence for infrastructure you would otherwise have to run yourself.
Prescriptions decide who gets in
Patients get access through a prescription or activation code, often for a limited period, while physicians and payers need their own, narrower view of the same data.
Clinical logic has to be traceable
Dosing calculations, risk scores and therapy steps must behave the same every time, and every version you release must be documented and reproducible.
Built on the Extra Horizon platform
Everything behind the app, already built
Build your digital therapeutic on a certified backend that already handles identities, patient data, clinical logic and releases — so your team can focus on the therapy and the evidence.
Identity & access management
Onboard patients through an activation code, give physicians and care teams scoped access, and let access end when the prescription does.
Learn more →Medical backend-as-a-service
Model therapy programs, sessions and questionnaire responses with your own schemas, and drive reminders and follow-ups with workflows and scheduled tasks.
Learn more →Diagnostics in the cloud
Run scoring, dosing and risk algorithms in your own cluster, triggered by new patient data, with every result stored alongside the record.
Learn more →Configuration as code
Keep your backend configuration in your own repository, so every release is versioned, reviewed and reproducible.
Learn more →Clinical studies & research
Run your clinical study on the same platform your product launches on, with the Research and Pre-Market licences.
Learn more →Regulations & certifications
Build on a platform certified to ISO 13485, ISO 27001 and IEC 62304, and inherit its evidence into your own technical documentation.
Learn more →Proven in software
From smartphone app to certified medical device
FibriCheck lets people check their heart rhythm with nothing more than their smartphone and get an immediate result. Built on Extra Horizon, the medically certified app has grown to more than 700,000 users in 40 countries, with over 6 million recordings made.
Read the FibriCheck case →Built for regulated software
Evidence for the software behind your therapy
Notified bodies, FDA reviewers and payers examine the backend of a software medical device as closely as the app. Build it on a platform that arrives with the evidence already in place.
IEC 62304 and the MDR
Software as a Medical Device needs a documented lifecycle. A qualified supplier certified to IEC 62304 and ISO 13485 covers the backend part of that file.
Reimbursement requirements
Reimbursement schemes such as Germany's DiGA add data-protection and security requirements of their own. A dedicated, certified deployment gives you a head start.
Health data protection
Therapy and mental-health data are special-category data under GDPR. A dedicated deployment in the region you choose, with scoped access, keeps them where they belong.
Let's talk about your digital therapeutic!
Get in touch, explain what you want to build, or have us help you build, and we'll get back to you ASAP! →