Platform

One platform, three engagement models.

The mHealth Suite takes your DTx through the Phase 1 block to a DiGAV-compliant, CE-marked product in 12 weeks – instead of typically 9–18 months for custom development. We operate it as your DTx Operations Partner and take it into further markets with statutory reimbursement and into emerging markets – all on the same platform foundation. Internationally, DUX is in market entry.

Book a call with Christoph The three phases
1 platform

indication-agnostic by design – recombine, don’t rebuild. The infrastructure was built once – not per product.

3 phases

Build · Scale · Go Beyond. A customer can enter at any phase; the platform carries all three.

90+ modules

pre-validated, reusable. Every new DTx starts on the same pre-validated foundation.

5 DiGAs

under contract on the mHealth Suite.

What the platform is

Not a product. The infrastructure for many products.

Classic DTx development treats every product as its own project: own architecture, own regulatory work, own QMS, own compliance audit. The result is projects that don’t stack – every new DTx starts from zero, and the time and cost curve grows linearly with the portfolio.

The mHealth Suite inverts the economics. Compliance, security, data protection and documentation are built once, platform-wide – within an ISO 13485-certified quality management system (TÜV Hessen) and under a BSI process certificate per TR-03185 for development. What is added per product is the clinical specificity: intended purpose, therapeutic modules, evidence strategy. That makes 12 weeks possible for the Phase 1 block up to the DiGAV-compliant, CE-marked product (Class I/IIa) – instead of typically 9–18 months for custom development.

Build, Scale and Go Beyond aren’t separate products but a continuous path on the same platform, adapted to the market context of your DTx: build it, operate it in regulated markets, distribute it in emerging markets.

The three engagement models

Two roles, three phases: DTx Operations Partner or DTx Distributor.

Phase 01 · Build · DTx Operations Partner

From concept to CE marking. Twelve weeks instead of typically 9–18 months for custom development.

You have a therapeutic concept and want a CE-marked product under MDR at DiGA compliance level. We configure a product from 90+ pre-validated modules – 12 weeks for the Phase 1 block up to the DiGAV-compliant, CE-marked product (Class I or IIa). For the standard scope: €100k setup + €15k/month operations, 12-month minimum term. Afterwards, operations continue through DUX as your DTx Operations Partner – with predictable monthly cost instead of a flat licence.
Go to BUILD page

Phase 02 · Scale · DTx Operations Partner

Additional indications. Structured regulated markets – EU, UK, US, CH.

Your DTx is listed in Germany. Next come additional indications and markets – DiGA-adjacent in the EU (FR PECAN, BE mHealthBelgium), the UK (NICE ESF), the US (FDA SaMD + diverse payer structures), Switzerland (MepV). DUX continues to operate your DTx as your DTx Operations Partner – as in Build, with predictable monthly cost per market instead of a flat licence. Internationally, DUX is in market entry.
Go to SCALE page

Phase 03 · Go Beyond · DTx Distributor

Emerging markets. Analogous to the pharma distributor.

You have a validated DTx. In emerging markets (LATAM, SEA, MENA, Sub-Saharan Africa) DUX is building a DTx Distributor model: national re-implementation, approval and ongoing operations – analogous to a pharma distributor. Compensation is via a revenue-share agreement.
Go to GO BEYOND page

Where the platform shows substance

Certified at process level, assessed per DiGA.

Since 1 January 2025, every DiGA needs a data security certificate under BSI TR-03161 (Section 139e (10) SGB V). TR-03185 additionally certifies the development process – with us as the first company. Our DiGAs assessed so far passed TR-03161 without conditions. Platform foundations are in place; DiGA evaluation runs per product.

BSI TR-03161

Assessed per DiGA

DiGAs assessed so far: pass 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

Which phase fits your project? Thirty minutes, honest assessment.

Tell us where you stand today – concept, listed DiGA or EU-validated DTx with global ambition. We’ll show you how the platform works for you.
Book a call with Christoph