mHealth Suite · The Platform

Digital therapeutics – built and operated on one platform.

We build your DTx to a CE-marked product under MDR in 12 weeks and operate it as your DTx Operations Partner. For further markets we offer the Operations Partner and the Distributor model; internationally, DUX is in market entry.

Book a call with Christoph The three phases
12 weeks

from therapeutic concept to a CE-marked product under MDR at DiGA compliance level. 12 weeks instead of typically 9–18 months for custom development.

90+ modules

pre-validated, indication-agnostic, combinable for your specific intended purpose. Compliance is part of the architecture.

14 years

of mobile expertise – the last seven as a Software-as-a-Medical-Device specialist. The first company to hold a BSI process certificate under TR-03185 (BSI-K-TR-0900-2026, 17 July 2026).

5 DiGAs

under contract on the mHealth Suite.

For investors

One platform. Multiple therapies. International growth.

We’re building on our digital therapeutics development and operations business to bring clinically validated therapies into additional markets. Our international licensing model is designed to combine therapeutic content, a shared platform and local partnerships. Internationally, DUX is in market entry.
Explore the investment case

Manifest · N°01 · Edition MMXXVI

DUX in five points

Platform, speed, evidence, price, provenance.

  • One platform instead of many projects. The mHealth Suite carries DiGAs and digital therapeutics indication-agnostically – compliance lives in the architecture, not in every customer project.
  • Twelve weeks to CE mark under MDR. Class I or IIa. Instead of typically 9–18 months for custom development.
  • BSI TR-03161: DiGAs assessed so far passed without conditions. BSI TR-03185: first company with a process certificate. Two core pieces of evidence; DUX was the first company to hold a BSI process certificate under TR-03185.
  • Predictable cost instead of project roulette. For the standard scope: €100k setup + €15k per month operations – including hosting, updates and compliance maintenance. Twelve-month minimum term.
  • Fourteen years of mobile, seven as an SaMD specialist. From Karlsruhe, since 2012 – with both co-founders as managing directors and an ISO 13485-certified QMS (TÜV Hessen).

What we do differently

A platform where compliance was solved once – not per product.

Classic development of digital therapeutics builds every product as its own project: custom architecture, custom regulatory work, custom post-market effort. Custom development typically takes 9–18 months to CE marking – per indication.

The mHealth Suite inverts the logic. It is the infrastructure your DTx runs on: indication-agnostic, modular, with highly automated MDR technical documentation, DiGAV alignment, BSI TR-03161 preparation per DiGA and an ISO 13485-certified QMS as part of the architecture. What gets configured on top for your product – therapeutic concept, content, interaction logic – builds on an audited foundation that was set up once and is maintained continuously.

The difference isn’t incremental. It’s structural.

The three phases

Build, Scale, Go Beyond – one entry point depending on where you are.

Phase 01 · Build

From therapeutic concept to a CE-marked product under MDR. Twelve weeks.

You have a clinical concept and want a CE-marked product under MDR at DiGA compliance level. We configure it from 90+ pre-validated modules. For the standard scope: €100k setup + €15k/month operations, twelve-month minimum term.
Go to BUILD

Phase 02 · Scale

DTx Operations Partner for additional indications and markets.

Your DTx is listed in Germany. Next come additional indications and markets – DiGA-adjacent routes in the EU (FR PECAN, BE mHealthBELGIUM), evidence framework in the UK (NICE ESF), the US (FDA) or Switzerland (MepV). As in Build, DUX as your DTx Operations Partner takes on operations, regulatory work and market interface – on the same platform foundation. Internationally, DUX is in market entry.
Go to SCALE

Phase 03 · Go Beyond

DTx Distributor for emerging markets.

You have a validated DTx and want to go further – into markets you would otherwise not have invested in. In the Distributor model, DUX as your DTx Distributor takes over national re-implementation, approval and ongoing operations in emerging markets (LATAM, SEA, MENA, Sub-Saharan Africa) – analogous to a pharma distributor. Internationally, DUX is in market entry. Compensation runs via revenue share.
Go to GO BEYOND

Knowledge Base · N°02 · Updated MMXXVI.10

From the knowledge base – what matters right now

Practical guides with paragraph citations and requirement IDs.

Go to the knowledge base

Evidence with substance

Certified at process level, assessed per DiGA.

For DiGAs the BSI lists two certificate types: product certificates under TR-03161 per DiGA, required by law, and process certificates under TR-03185 – DUX was the first company to hold a BSI process certificate under TR-03185. Our DiGAs assessed so far passed TR-03161 without conditions. TR-03161: mandatory for DiGAs since 01.01.2025, formally application-relevant since 01.07.2025.

BSI TR-03161

Assessed per DiGA

DiGAs assessed so far: passed without conditions.

Cybersecurity · certified per DiGA.

BSI TR-03161 is awarded per DiGA – not per organisation. The DiGAs on our platform assessed so far passed without conditions.

BSI TR-03185

First certified 17 July 2026

First company to hold this process certificate.

Secure software development lifecycle.

DUX Healthcare was the first company to hold a BSI process certificate based on TR-03185: BSI-K-TR-0900-2026, issued 17 July 2026, valid until 16 July 2029. The certified scope is the software development process for digital health applications (DiGA).

Baseline

ISO 13485

Quality management for medical devices – certified (TÜV Hessen)

Next step

Thirty minutes. Your intended purpose. An honest assessment.

A short conversation: whether the mHealth Suite fits your project and, if so, where we would start – Build, Scale or Go Beyond.
Book a call with Christoph