All-in-one instead of hidden costs
From Setup to Continuous Compliance
We designed our model to foster innovation, not hinder it. That is why there are no high upfront investments and no unpredictable additional costs.
- Cost certainty: No surprises with maintenance or regulatory updates
- Scalability: For startups and Big Pharma alike — we support your growth
- Regulatory compliance included: CE-ready in 8 weeks with complete MDR documentation
- Fast market access: MVP, mHealth app, Companion or DiGA — ready to launch
Cost-efficient DTx, DiGA, Pharma Companion App product development
Exclusive at DUX Healthcare
One-time setup fee
typically € 100k
Product development & compliance
- Onboarding Configuration and integration of your therapy-specific content
- Product development (CE-ready) Access to over 80+ pre-validated DTx components
- Regulatory support
Monthly fee
typically € 15k
Ongoing development, compliance & operations
- Hosting & operations
- Release management
- Technical & regulatory updates (MDR, GDPR, DiGAV, BSI-TR03161)
- Maintenance & support (2nd/3rd level)
- Ongoing development
Minimum term: 12 months, billed annually in advance
For those who want more: Our all-inclusive package
Optional Add-Ons
Regulatory & External Placing on the Market
- Intended purpose
- Risk management
- Clinical evaluation
- Declaration of Conformity
€ on request, optional
Medical Content Services
- Creation or revision of medical content — including AI-assisted
- Content preparation according to design guidelines
€ on request, optional
Custom Functionality
- Development of new modules specifically for your indication
- Exclusive usage licenses available if needed
€ based on effort, optional
Interfaces & Data Integration
- Integration of external systems (e.g. wearables, ePA, e-prescription, Health ID)
- Connection to your internal systems or partner solutions
€ based on effort, optional
Collaborative Process
You provide the therapy concept — we deliver the market-ready digital product. Our platform combines indication-agnostic software with individual customization. Once the functionalities are defined, development begins; content can be finalized in parallel. You supply all medical information — we guide you through an efficient, flexible workflow.
The prices listed here are for guidance purposes and do not constitute a binding offer.
FAQ
Getting Started
Is the mHealth Suite a platform I can use myself?
No — the mHealth Suite is not a self-service tool but our internal manufacturing framework. You receive a finished product on our proven infrastructure — including development, operations, and regulatory assurance. You provide the therapy concept — we take care of implementation, certification, and maintenance.
What does the mHealth Suite offer — and how does it support my product idea?
The mHealth Suite is a scalable platform used by DUX Healthcare to develop CE-certified digital health applications in as little as three months.
You benefit from over 80 pre-validated DTx modules, automated Technical Documentation, and integrated regulatory compliance (MDR, DiGAV, BSI TR-03161, BfArM data protection criteria). The scalable development platform enables predictable costs through a transparent subscription model and drastically reduces development and certification timelines as well as maintenance effort.
Whether DiGA, DiPA, Pharma Companion App, DTx, or lifestyle product — the solution is indication-agnostic and customizable to your therapeutic content.
How does the mHealth Suite pricing model work?
After a one-time setup fee for configuration and integration, you pay a monthly subscription fee. Minimum term: 12 months. Included are hosting, maintenance, compliance services, support, and ongoing development. Additional services can be added optionally.
How quickly can I go live with my digital product?
Approximately 3 months from kick-off to completion of product development including CE marking Class I and IIa. A lifestyle MVP can typically be CE-ready as early as 8 weeks after project start. Pre-validated components and automated documentation reduce development and certification time by up to 80%.
What types of health products can DUX Healthcare build for me?
With the mHealth Suite, we develop digital health solutions of all kinds:
- Health software & lifestyle apps — also without CE, ideal for prevention, wellbeing, or initial MVPs with a later upgrade path
- Medical device software / medical apps — Class I, IIa, or IIb, fully MDR-compliant, CE-certified according to ISO 13485 and ISO 27001
- Pharma Companion Apps — digital companions for Rx products, OTC, or Orphan Drugs
- Digital Health Applications (DiGA) — in compliance with DiGAV, BSI TR-03161, and BfArM data protection criteria
Compliance & Certification
Who takes on the role of Legal Manufacturer?
Either you or our certified regulatory partner. Both paths are supported by complete MDR-compliant documentation and ISO 13485-compliant processes.
Does the mHealth Suite cover all regulatory requirements?
Yes. MDR, DiGAV/DiPAV, BSI TR-03161, and BfArM data protection criteria. Additional features such as ePA integration or Health ID are available on request.
After Launch
What does DUX Healthcare handle after launch?
Hosting, compliance maintenance, release management, monitoring, and ongoing development — all covered by the subscription fee.
Can I expand my product with new features or indications later?
Absolutely. The modular system allows extensions — new features, indications, or content — without jeopardizing CE certification. If a desired feature does not yet exist, DUX Healthcare can develop custom features that fully integrate into the existing infrastructure.
Will my app be kept technically up to date?
Yes. By using the mHealth Suite platform, you receive a comprehensive service package: product maintenance & upkeep, hosting & operations, regular software updates, release management, 2nd and 3rd level support.
Scaling & Flexibility
Is it possible to scale the app for additional indications or target groups?
Yes, thanks to the modular architecture of the mHealth Suite, the app can be easily adapted for additional indications. Existing features and Technical Documentation can be reused, saving time and costs. New medical content is simply added and linked with the appropriate modules.
Can custom modules be added?
Yes, custom modules can be added at any time. If a desired feature is not included in the standard scope, DUX Healthcare develops tailored add-on modules that integrate seamlessly into the platform. These modules are validated, documented, and fully compatible with regulatory requirements. On request, you can even receive exclusive usage rights.
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