# DUX Healthcare

> DUX Healthcare GmbH (formerly fluidmobile GmbH) is an ISO 13485-certified technology provider based in Karlsruhe, Germany. Founded in 2012, DUX Healthcare develops CE-certified digital health applications using the mHealth Suite – a scalable platform with 80+ pre-validated DTx modules for DiGA, DiPA, Digital Therapeutics (DTx), and Pharma Companion Apps. The company achieves CE certification (Class I/IIa) in as little as 3 months through its innovative Software as a Medical Device (SaMD) manufacturing process.

## Products & Services

- [mHealth Suite Platform](https://dux-healthcare.com/mhealth-suite/): Scalable development platform for CE-certified digital health solutions. 80+ pre-validated DTx modules, automated MDR-compliant technical documentation, and integrated regulatory compliance.
- [DiGA Development](https://dux-healthcare.com/diga-entwicklung/): MDR-compliant DiGA product development and CE certification in 3 months. DiGA transfer of existing apps in 2–3 months. Full DiGAV, BSI TR-03161, and BfArM data privacy compliance.
- [DiPA Development](https://dux-healthcare.com/dipa/): Digital care application development with UX research in care settings. DiPAV-compliant, certified, and scalable.
- [Pharma Companion Apps](https://dux-healthcare.com/pharma-companion-app/): Therapy- and indication-specific companion apps for Rx, OTC, and Orphan Drugs. CE-certified, HWG-compliant, MDR-ready.
- [Medical Software / SaMD](https://dux-healthcare.com/medical-software-entwicklung/): CE-certified medical device software development. Class I, IIa, or IIb. Full MDR compliance with ISO 13485 and ISO 27001.

## Key Facts

- 80+ pre-validated DTx software modules
- CE certification in 3 months (Class I/IIa)
- ISO 13485 certified (Quality Management System for Medical Devices)
- ISO 27001 compliant (Information Security Management)
- BSI TR-03185 certified – first company ever to achieve this certification
- BSI TR-03161 certification for apps achieved without conditions
- BfArM Datenschutzprüfkriterien (data privacy criteria) compliant
- DSGVO/GDPR compliant
- Founded 2012, based in Karlsruhe, Germany
- Subscription model: setup from €100k, monthly from €15k

## Pricing

- [Pricing Model](https://dux-healthcare.com/preismodell/): Transparent subscription-based pricing. One-time setup fee for configuration, integration, and CE-ready product development. Monthly leasing fee covering hosting, maintenance, compliance services, support, and ongoing development. 12-month minimum term.

## Company

- [About DUX Healthcare](https://dux-healthcare.com/ueber-dux-healthcare/): Company history, team, vision and mission. Technology provider of the mHealth Suite since 2012.
- [Jobs](https://dux-healthcare.com/jobs/): Open positions at DUX Healthcare in Karlsruhe.
- [Contact](https://dux-healthcare.com/contact-us/): Reach the DUX Healthcare team. Phone: +49 721 754 072 39. Email: kontakt@dux-healthcare.com.