We Solve Challenges in DiPA Development
Challenge 1: High Upfront Costs, Uncertain ROI
Traditional custom development consumes budget for infrastructure, compliance, and validation — before product-market fit is proven. Innovation becomes risky and inflexible.
Challenge 2: Strict Regulations
Reimbursability under Section 78a SGB XI and the DiPAV requires MDR conformity as well as data and IT security audits (BSI TR-03161). If implementation fails, it costs time and money.
Challenge 3: High Quality Requirements, Few Guidelines
DiPAs must holistically combine technology, security, efficacy, and UX — yet a proven framework is lacking. Teams struggle to meet the requirements efficiently.
Challenge 4: Unclear Usability Requirements
Authorities require “accessibility appropriate to care dependency levels.” Uncertainty delays approvals.
Our Promise
From idea to certified DiPA. With UX research in care settings, robust technology, and well-founded regulatory expertise, we minimize your risks early on.
How DiPA Manufacturers Benefit from the mHealth Suite
Time to Market
Pre-validated modules and clear guidelines reduce trial and error: your product launches in months rather than years — with lower costs and fewer setbacks in certification.
Built-In Regulatory Compliance
ISO 13485-certified technology provider. Our infrastructure meets MDR requirements, BfArM data protection review criteria, and BSI TR-03161 compliance — making your path through the DiPA process significantly shorter.
Care-Centered Design
Our pre-validated modules address all user groups — from digitally proficient caregivers to individuals with cognitive or motor impairments.
Want to Learn More?
The mHealth Suite
80+ pre-validated DTx modules. Fast. Cost-efficient. Individually customizable. Tailored to your therapy concept. Quality and compliance are built in from the start.
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 production framework that we use to develop your digital health application. You receive 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 for developing CE-certified digital health applications in just three months. You benefit from over 80 pre-validated DTx modules, automated Technical Documentation, and integrated compliance (MDR, DiGAV, BSI TR-03161, BfArM data protection review criteria). The solution is indication-agnostic and can be customized to your therapy content.
How quickly can I go live with my digital product?
Around 3 months from kick-off to completion of product development including CE marking. Pre-validated components and automated documentation reduce development and certification time by up to 80%.
How does the mHealth Suite pricing model work?
After a one-time setup fee, you pay a monthly subscription fee. Minimum term: 12 months. Included are hosting, maintenance, compliance services, support, and ongoing development.
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.
Does the mHealth Suite cover all regulatory requirements for DiGA and DiPA?
Yes. The mHealth Suite meets MDR, DiGAV/DiPAV, BSI TR-03161, as well as the BfArM data protection review criteria. 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?
Hosting, compliance maintenance, release management, monitoring, and ongoing development — all covered by the subscription fee.
Can I expand my product later?
Yes. The modular system allows expansions — new features, indications, or content — without jeopardizing CE certification.
Scaling & Flexibility
Is scaling to additional indications possible?
Yes, thanks to the modular architecture, your app can be easily adapted for additional indications. Existing features and documentation can be reused, saving time and costs.
Can custom modules be added?
Yes. Tailored add-on modules are seamlessly integrated, validated, and documented. Exclusive usage rights are available upon request.
Contact our experts