A doctor in a white coat with a stethoscope holding a smartphone displaying a medical app interface.

Digital Health, Built Smarter

with the mHealth Suite by DUX Healthcare

mHealth Suite Platform – DiGA Development, DTx & Pharma Companion Apps

The mHealth Suite platform as the technological foundation for digital health applications.

Our Platform Approach

Your CE-certified mHealth product on the market in just 3 months

At DUX Healthcare, we are redefining how regulated digital health products are built. As a platform provider, we deliver more than code – we provide the regulatory foundation, modular software architecture, and long-term operational reliability.

Our innovative manufacturing framework for Software as a Medical Device (SaMD) enables pharmaceutical companies, DiGA and DiPA manufacturers, startups, and health tech innovators to launch faster, scale smarter, and maintain seamless compliance.

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mHealth Suite partner companies: Fraunhofer IMS, 4L Health, certmedica, derma2go.

Our Claim? Delivered!

From startups and DiGA manufacturers to pharmaceutical companies

Established companies already rely on the mHealth Suite to minimize regulatory risks, meet the highest standards, and bring digital mHealth products to market efficiently, securely, and at scale.
CLIENTS & PARTNERS
Visualization of the mHealth Suite platform – modular digital health architecture.

The mHealth Suite

The technology solution that adapts to your specific medical purpose

The mHealth Suite is your fast track to digital health products – tailored to your therapeutic concept. Not a cookie-cutter toolkit, but a modular and scalable system built for the highly regulated healthcare industry. Over 80 pre-validated software modules and automated documentation allow you to focus on medical innovation while we handle the complexity.
DISCOVER

Scalable Platform for Regulated Digital Medical Devices (SaMD)

DUX Healthcare is a pioneer in the scalable manufacturing of Software as a Medical Device (SaMD). The mHealth Suite is a highly modular, reusable platform with over 80 pre-validated components. It not only enables faster CE certification but also significantly reduces development, maintenance, and operational costs.
mHealth Suite – Unmatched Speed

Unmatched Speed

Bring your CE-certified product to market in just 3 months instead of 18. Pre-validated modules and compliance-ready infrastructure turn time-to-market into a competitive advantage.
mHealth Suite – Seamless Scalability

Seamless Scalability

Scale horizontally into new markets or vertically into new indications – all from a single platform. You drive strategy and content; we deliver the certified growth infrastructure.
mHealth Suite – Automated Documentation

Automated Documentation

Technical Documentation generated in parallel with development – audit-ready by design. Built-in MDR and ISO workflows save months of regulatory effort.

Revolutionary Product Development –
Three approaches tailored to your starting point.

Pharma Companion Apps

Pharma Companion Apps

Looking for a digital companion to an existing drug or medical device? We develop Pharma Companion Apps for Rx, OTC, orphan drugs, and dietary supplements in record time – including CE certification where required.
SOLUTIONS
DiGA Development & DiGA Transfer

DiGA Development & DiGA Transfer

Migration of existing DiGAs to the mHealth Suite – for greater compliance, security, and scalability. We deliver BSI TR-03161 compliance! In addition to DiGA transfer, we also offer full development of new DiGAs.
SOLUTIONS
DiPA Development

DiPA Development

The mHealth Suite provides the ideal development framework to build the first DiPA in a regulatory-compliant, secure, and scalable way – with a special focus on UX!
SOLUTIONS

You provide the therapeutic concept – we deliver the market-ready digital product.

Our platform combines indication-agnostic software with individual customization.

The process starts with the therapeutic approach: our partners or clients provide the medical concept and domain expertise.

In parallel with content creation, technical implementation begins. Thanks to our highly modular platform architecture, product development starts immediately.

After approximately eight weeks, we deliver a complete MDR-compliant documentation package, enabling clinical evaluation and CE certification to proceed.

Launch can take place as early as three months after development begins.

On request, DUX Healthcare and its partners can support certification and market entry – alternatively, the client can act as the legal manufacturer themselves and bring the product to approval using the documentation provided.

The collaboration process: DUX Healthcare as the technology provider of the mHealth Suite.

About DUX Healthcare

What sets us apart

DUX Healthcare is ISO 13485 certified.

ISO 13485 Certified

DUX Healthcare provides ISO 27001-compliant hosting.

ISO 27001-Compliant Hosting

DUX Healthcare brings over 14 years of experience.

14 Years of Expertise

The transition from fluidmobile GmbH to DUX Healthcare.

From fluidmobile to DUX Healthcare – what's changing and what stays the same

Since early 2026, we operate as DUX Healthcare – formerly fluidmobile GmbH. DUX Healthcare GmbH (formerly fluidmobile GmbH) is your legal contracting partner, data processor, and compliance entity.

For you, only the name changes – our contracts and our focus on certified products remain the same.

ABOUT US

Looking for a solution to your mHealth challenges?

Regulatory complexity, data security, or rapid scale-up – the path to a finished mHealth product can be long and challenging.

With the mHealth Suite, we support pharmaceutical companies, health tech startups, and DiGA/DiPA manufacturers with product strategy, digital health, and marketing. We also evaluate the regulatory and strategic framework for your product.

Let’s turn your concept into a compliant, scalable product together.

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