mHealth Suite · The Platform

Digital therapeutics – built, operated, globally distributed.

We build your DTx to a CE-marked product under MDR in 12 weeks, operate it as your DTx Operations Partner in every market with statutory reimbursement – and distribute it as your DTx Distributor in emerging markets. All on the same platform foundation.

Book a call with Christoph The three phases
12 weeks

from therapeutic concept to a CE-marked product under MDR at DiGA compliance level. Three to six times faster than classic in-house development.

80+ 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 audited against BSI TR-03185.

5 DiGAs

on the mHealth Suite today – platform-built, BSI-compliant, CE-marked under MDR.

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. Three to six times faster than classic in-house development.
  • BSI TR-03161 without conditions. BSI TR-03185 audited as the first company. Two core pieces of evidence with a combination rarely found together in the German DiGA market.
  • Fixed price instead of project roulette. €100k setup + €15k per month – including hosting, updates and compliance maintenance. Minimum term: twelve months.
  • Fourteen years of mobile, seven as an SaMD specialist. From Karlsruhe, since 2012 – with continuous technical leadership and an audited QMS as the operating foundation.

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. Nine to eighteen months to CE certification and six- to seven-figure development costs – per indication, per market.

The mHealth Suite inverts the logic. It is the infrastructure your DTx runs on: indication-agnostic, modular, with MDR conformity assessment, DiGAV alignment, BSI TR-03161 preparation per DiGA and an ISO framework 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 80+ validated modules. Fixed price: €100k setup + €15k/month operations, twelve-month minimum term.
Go to BUILD

Phase 02 · Scale

DTx Operations Partner across every structured regulated market.

Your DTx is listed in Germany. Next come additional indications and markets – DiGA-adjacent in the EU (FR PECAN, BE mHealthBelgium, UK NICE-ESF), the US (FDA SaMD + Commercial/Medicare/VA/Employer) or Switzerland (MepV + KVG/private). As in Build, operations, regulatory work and market interface run through DUX as your DTx Operations Partner – on the same platform foundation, with predictable monthly cost instead of a flat licence per market.
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 emerging markets (LATAM, SEA, MENA, Sub-Saharan Africa) DUX takes over national re-implementation, approval and ongoing operations as your DTx Distributor – analogous to a pharma distributor. You receive revenue via revenue share, with no upfront cost and no market risk of your own.
Go to GO BEYOND

Knowledge Base · N°02 · Updated MMXXVI.04

From the knowledge base – what matters right now

Practical guides with paragraph citations and requirement IDs. Written by the people who run BSI audits and BfArM applications every day.

Go to the knowledge base

Evidence with substance

Audited on process and product level.

Two BSI standards matter for the German DiGA market: TR-03185 on the process level – with us as the first company audited against it – and TR-03161 on the product level, per DiGA. The DiGAs on our platform passed TR-03161 without conditions. Mandatory for DiGAs since 01.01.2025, formally application-relevant since 01.07.2025.

BSI TR-03161

Rare in Germany

Our DiGAs: pass without conditions.

Cybersecurity · certified per DiGA.

BSI TR-03161 is awarded per DiGA – not per organisation. Most DiGAs only reach it with formal conditions; the DiGAs on our platform passed without conditions – a combination rarely seen in Germany.

BSI TR-03185

First audit

Audited as the first company.

Secure software development lifecycle.

DUX Healthcare is the first company to have completed a BSI TR-03185 audit – the formal certificate is pending. The audit covered the entire development process from requirements through implementation to release.

Baseline

ISO 13485

Quality management for medical devices – certified (TÜV Hessen)

ISO 27001

Information security management system – audited under BSI TR-03185 · separate third-party certificate to follow

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