Doctor using DiGA app on tablet – digital health application

DiGA Development – CE Certification in Just 3 Months

From your finished concept to an MDR-compliant patient app with completed CE certification in 3 months

We Solve Challenges in DiGA Development

Challenge 1: Complex & Evolving Regulations

MDR, DiGAV, BfArM data protection review criteria, and BSI TR-03161 place demanding requirements on DiGA manufacturers. Together, they form a complex documentation package requiring compliance, data security, interoperability (e.g., with the ePA), and Health ID integration. Without deep expertise, this becomes a real challenge — both technically and organizationally.

Challenge 2: High Upfront Costs, Uncertain ROI

Traditional custom development consumes budget early on for CE certification, validation, infrastructure, and clinical studies — before a positive care effect has been demonstrated or real DiGA value has been proven. Without a modular platform, risk increases — especially for young manufacturers.

Challenge 3: No Room for Trial & Error

Without a well-thought-out strategy, the first version often fails at CE certification, risk assessment, or in the BfArM process or DiGA Fast Track procedure. Rework or even a complete restart delays market entry and causes unnecessary costs. A solid foundation from day one is critical.

Challenge 4: Lack of Scalable Infrastructure

Scalable infrastructure is a fundamental prerequisite for operations, IT security, monitoring, and continuous development — especially given regulatory requirements such as release workflows or BSI compliance. Building it in-house ties up resources, slows momentum, and carries unnecessary risks — particularly when expanding to additional indications.

Our Promise

We typically bring your application to MDR-compliant product development and completed CE certification in just three months after project start — as a Class I or IIa medical device.

Our platform meets all technical requirements of the DiGAV, the BfArM data protection review criteria, and BSI TR-03161, and is ready for ePA connectivity and Health ID integration.

This gives you the technical and regulatory foundation for your DiGA — whether as a new development or a rapid transfer of existing solutions in just 2–3 months. We can also support the evaluation of the positive care effect with clinical study partners upon request.

How DiGA Manufacturers Benefit from DiGA Development with the mHealth Suite

DiGA Transfer

DiGA Transfer

Secure DiGA transfer to our platform — in just 2–3 months. Your existing DiGA is technically modernized, made regulatory-proof for the future, and fully ready for BSI TR-03161 certification. Benefit from scalable infrastructure for additional indications.
MDR & Documentation

MDR & Documentation Built In

MDR-compliant auto-generated tech files are created automatically — audit-ready, up-to-date, and efficient, ensuring your audit security. Regulatory excellence is an integral part of the platform architecture, allowing companies to benefit from significantly reduced complexity and scalability from the very start.
Stay Listed & Stay Secure

Stay Listed & Stay Secure

Security updates, release workflows, and monitoring included: your DiGA stays compliant — without internal ops overhead. Your DiGAV compliance, BSI TR-03161 compliance, implementation of all BfArM data protection review criteria, ePA connectivity, and Health ID integration are all taken care of.
mHealth Suite Development Platform

Want to Learn More?

DiGA Development with the mHealth Suite

  • Innovative manufacturing framework for Software as a Medical Device (SaMD)
  • Scalable development platform for CE-certified medical devices — for DiGAs, Pharma Companion Apps, and Digital Therapeutics (DTx)
  • Auto-generated MDR-compliant Technical Documentation audit-ready at the push of a button
  • Automated Software Verification & Validation (V&V) for greater compliance and fewer risks
  • 80+ pre-validated DTx modules individually recombined and tailored to your medical intended purpose
  • Indication-agnostic flexibly adaptable to your target indication — from chronic diseases to preventive care offerings
  • Subscription model transparent, predictable costs with full scalability — ideal for startups, pharma, DiGA, and DiPA manufacturers
  • Scalability in focus from MVP to international rollout
LEARN MORE

FAQ on the mHealth Suite and DiGA Development

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 production framework that we use to develop your digital health application. Think of it as our “digital production line” for CE-certified medical apps, DiGAs, and Companion Apps — developed by fluidmobile GmbH for our own use.

You don’t receive a platform you have to operate yourself, but rather a finished product built 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 just 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 review criteria). The scalable development platform enables predictable costs through a transparent subscription model and drastically reduces development and certification time as well as maintenance effort.

Whether DiGA, DiPA, Pharma Companion App, DTx, or lifestyle product — the solution is indication-agnostic and can be customized to your therapy content. You provide the therapy concept — we deliver the regulatory infrastructure.

How quickly can I go live with my digital product?

A typical project timeline with a nearly complete concept is around 3 months from kick-off to completion of product development including Class I and IIa CE marking. A lifestyle MVP can typically be CE-ready within 8 weeks of project start.

Pre-validated components and automated documentation reduce development and certification time by up to 80% compared to conventional approaches. A transfer of an existing DiGA can be completed in 2–3 months, while a full DiGA development including clinical study and DiGA application with BfArM takes approximately 12 months.

How does the mHealth Suite pricing model work?

The mHealth Suite offers a transparent and predictable cost structure. After a one-time setup fee for configuration and integration, you pay a monthly subscription fee. Exact flat-rate pricing is available upon request.

The minimum term of the subscription model is 12 months. The monthly subscription fee includes hosting, maintenance, compliance services, support, and ongoing development. Additional services such as external CE certification or exclusive modules can be added optionally.

What types of health products can DUX Healthcare develop for me?

With the mHealth Suite, we develop digital health solutions of all kinds:

  • Health software & lifestyle apps — even 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 review criteria
Compliance & Certification
Who takes on the role of Legal Manufacturer?
Either you take on this role yourself or you engage our certified regulatory partner. Both paths are supported by complete MDR-compliant Technical Documentation and ISO 13485-compliant processes. You decide flexibly based on what best fits your internal structure and regulatory strategy.
Does the mHealth Suite really cover all regulatory requirements for DiGA and DiPA?
Yes. The mHealth Suite meets the requirements of the MDR, the requirements of the DiGAV/DiPAV including BSI TR-03161, as well as the BfArM data protection review criteria, making it ideally suited for DiGA and DiPA manufacturers. We also offer additional features such as ePA connectivity, Health ID, or prescription billing upon request.
After Launch
What does DUX Healthcare handle after my app launches?
We continue to handle hosting, compliance maintenance, release management, monitoring, and many typical ongoing development tasks — all covered by the subscription fee. This keeps your product permanently secure, up-to-date, and market-ready — without additional complexity for your team.
Can I expand my product with new features or indications later?
Absolutely. The modular system allows expansions — new features, indications, or content — without jeopardizing CE certification. If a desired feature doesn’t 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, your 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 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. Exclusive usage rights are available upon request.

Contact our experts

Let's get your DiGA listed.

DUX Healthcare GmbH (ehem. fluidmobile)

Bachstraße 43 76185 Karlsruhe +49 721 754 072 39 contact@dux-healthcare.com