Platform

One platform, three engagement models.

The mHealth Suite takes your DTx from therapeutic concept to CE marking under MDR in 12 weeks. We 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
1 platform

indication-agnostic, modular, MDR- and DiGAV-ready as a compliance substrate. 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, regulatorily covered. Every new DTx starts on the certified substrate.

5 DiGAs

under contract on the mHealth Suite. Platform-built, BSI-compliant, CE-marked under MDR.

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 and certified once, platform-wide. What is added per product is the clinical specificity: intended purpose, therapeutic modules, evidence strategy. That makes CE marking under MDR (Class I/IIa) of a DiGA possible in twelve weeks – and the second DiGA noticeably faster than the first.

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, not twelve months.

You have a therapeutic concept and want a CE-marked product under MDR at DiGA compliance level. We configure a product from 90+ validated modules that carries the CE mark (Class I or IIa) in twelve weeks – across four parallel workstreams. For the standard scope: €100k setup + €15k/month operations. 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, US, CH.

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 + 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.
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 takes over national re-implementation, approval and ongoing operations as your DTx Distributor – analogous to a pharma distributor. You receive revenue from these markets via revenue share, with no upfront cost and no market risk of your own.
Go to GO BEYOND page

Where the platform shows substance

Certified 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 certified against it – and TR-03161 on the product level, per DiGA. The DiGAs on our platform passed TR-03161 without conditions. Platform foundations are in place; DiGA evaluation runs per product.

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 and obligations to remedy; the DiGAs on our platform passed without conditions – a combination rarely seen in Germany.

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 – from requirements through implementation to release. Updates do not require re-auditing.

Baseline

ISO 13485

Quality management for medical devices – certified (TÜV Hessen)

ISO 27001

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

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