Company · About us

Fourteen years of mobile. Seven of them as a medical device software specialist.

DUX Healthcare emerged from fluidmobile GmbH. Platform before project – the consequence of 14 years of mobile software, the last 7 as a Software-as-a-Medical-Device specialist.

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2012 Karlsruhe

Founded as fluidmobile GmbH in Karlsruhe.

14 years

Mobile expertise – the last seven years as a Software-as-Medical-Device specialist.

2 BSI standards

TR-03161 assessed per DiGA (our DiGAs assessed so far: without conditions) · TR-03185 first company certified (process level).

5 DiGAs

under contract on the mHealth Suite.

Our history

From mobile service provider to platform company.

  1. Founding · fluidmobile GmbH

    Mobile software development for clients. With every project, specialization grew toward medical device software.

  2. Focus · Software as a Medical Device

    Medical device software becomes the focus.

  3. Quality management · ISO 13485

    ISO 13485-certified quality management system (TÜV Hessen).

  4. Rename · DUX Healthcare GmbH

    The name positions more clearly what the company is today: platform provider for digital therapies, not a mobile service provider with a healthcare business. Five DiGA projects are under contract and being developed on the Suite.
Karlsruhe since 2012Same company, new name (HRB 714595)

From custom build to platform

The mHealth Suite is the distillate of recurring requirements.

Every DiGA manufacturer needs the same regulatory base – MDR-compliant documentation, BSI TR-03161-capable architecture, BfArM Data Protection Criteria, interoperability under §§ 6, 6a DiGAV (FHIR, ePA export). Built from scratch per project, the path to CE conformity typically takes 9–18 months; on the platform, 12 weeks for the Phase 1 block up to the DiGAV-compliant, CE-marked product.

Regulatory leadership

The certifications are timing, not marketing.

For BSI TR-03185, DUX was the first company to hold a BSI process certificate (BSI-K-TR-0900-2026). The breakdown per standard is on the certifications page; here are the two that shape DUX most clearly.

BSI TR-03185

First certified 17 July 2026

First company to hold this process certificate.

Secure software development lifecycle – process certificate, assessed against TR-03185.

Certificate BSI-K-TR-0900-2026, issued 17 July 2026, valid until 16 July 2029. Assessment body: secuvera GmbH.

BSI TR-03161

Assessed per DiGA

Our DiGAs assessed so far: passed without conditions.

Cybersecurity – certified per DiGA.

Baseline

ISO 13485

Quality management for medical devices – certified by TÜV Hessen (TÜV PROFiCERT)

BfArM Data Protection Criteria

criteria under § 139e (11) SGB V – evidence is part of our QMS

The team

Small. Experienced. Operationally involved.

Anyone working with DUX talks to the people who actually deliver – audit calls, architecture reviews, project decisions run without an account-manager chain in between.
Christoph Eberhardt – Owner & CEO

Owner & CEO

Christoph Eberhardt

Christoph Eberhardt, CEO and founder of DUX Healthcare, combines technical expertise with entrepreneurial thinking. His deep understanding of emerging technologies, such as generative AI, drives the development of tailored software solutions for the medical device and pharmaceutical industries. His goal is to effectively link technology and business value to generate maximum benefit for his clients.

LinkedIn
Mia Burniki – Business Development Manager

Business Development Manager

Mia Burniki

Mia Burniki brings a strong combination of Cognitive Science and Digital Medicine. Her specialization in Regulatory Affairs Management makes her an expert in the digital medical device space. She successfully identifies new business opportunities and drives the strategic development of DUX Healthcare.

LinkedIn
Thomas Wolters – CTO

CTO

Thomas Wolters

CTO, business IT specialist, and project lead with over 20 years of experience in software development at international corporations and German mid-sized companies. He leads a growing team of top-tier experts and is passionate about delivering outstanding user experiences.

LinkedIn

What guides us

Three values. No wall posters.

The three values below can be read off actual behavior – that is the only reason we mention them.

Substance

Audited, not asserted.

We publish what has been certified or audited – and stay silent on what cannot be proven. The digital health industry’s marketing dictionary is full of “something-compliant”. We speak concretely: BSI TR-03161 assessed per DiGA (our DiGAs assessed so far: without conditions), BSI TR-03185 first company certified (process level), ISO 13485 certified (TÜV Hessen). ISO 27001 is in progress, we do not hold a certificate yet. What is not on the list, we do not claim.

Platform

What is solved once is not rebuilt per project.

Compliance, security, and architecture arise once – at platform level – and carry every customer project. This logic applies internally (we do not build one-day products) and externally (we do not recommend one-day solutions).

Honesty

If the platform does not fit, we say so.

Not every project is a good project for the mHealth Suite. If a use case does not need the platform or overwhelms it, we say so in the first call – and point to better-suited providers. Long-term reputation is worth more than any single contract.

What DUX does not do

Two honest boundaries.

We are not a content company. DUX delivers the platform, the regulatory corset, and the technical excellence – not the therapeutic content. The therapeutic concept, medical expertise, and clinical evidence remain with the customer or their partners.

We are not a clinical evidence shop. Clinical evaluation under the MDR and the study demonstrating positive healthcare effects (§ 10 DiGAV) are not part of our core business. For regulatory consulting and clinical evidence we work with CONSULTYS Medical GmbH, for BSI TR-03161 with the BSI-recognised test lab secuvera GmbH. For the manufacturer role: be-on-market GmbH, our partner for placing medical devices on the market (legal manufacturer under the MDR).

This sharp separation is what keeps the platform in focus – and lets the customer keep focus on what they do better than we do.

Where we are headed

Three directions.

Strategic directions for the coming years – two that extend the platform logic into new markets, and one that protects the regulatory lead.

  1. SCALE

    European multi-market operations

    We are systematically building out SCALE. Internationally, DUX is in market entry; localization layers are meant to address the fragmentation after German market entry.
    To SCALE

  2. Go Beyond

    Emerging markets, controlled

    We are expanding GO BEYOND in a controlled manner. Emerging markets rollouts require local partners; we select them along robust criteria, not by presentation slide.
    To Go Beyond

  3. Regulatory

    Preserve the lead

    We continue to invest in the regulatory lead. DUX assessment: we aim to be audit-ready early for upcoming BSI requirements.
    To the certifications
For the capital side: further materials on the investors page.

Contact

Thirty minutes directly with Christoph.

Book a slot in the calendar. We listen first before we answer.
Book a slot with Christoph