Challenges in Medical Device Software Development (SaMD)
Challenge 1: High Entry Costs
Building your own compliant infrastructure is expensive and time-consuming – especially with a limited budget and tight timelines.
Challenge 2: Risk of a Non-Compliant MVP
Without proper documentation and testing, your MVP won’t meet regulatory requirements – and cannot be placed on the market.
Challenge 3: Limited Regulatory Know-How
Tackling MDR, DiGAV/DiPAV, BSI TR-03161, BfArM data protection criteria, and CE certification without experience is risky and resource-intensive – especially without an in-house compliance team.
Challenge 4: No In-House IT Ops & Secure Hosting
Startups shouldn’t have to host, monitor, or maintain infrastructure themselves. Yet many solutions require exactly that.
Our Promise
CE-certified medical device apps in record time. A CE-ready MVP in just a few weeks. A clear path to DiGA or DiPA eligibility. And a platform that grows with your product.
Whether DTx, digital companion therapy, or DiGA: if you want to develop an app as a medical device, we handle the regulatory complexity for you. With the mHealth Suite, we deliver product development including CE certification in just 3 months.
DUX Healthcare – Your Technology Partner
How You Benefit from the mHealth Suite
Time-to-Market
Reduce 12–18 months of development time to just 3 months. Your CE-certified product is built in parallel with your market launch.
Affordable Entry, Scalable Growth
Subscription model with manageable monthly costs: validate, grow – without costly rebuilds or technical debt.
Compliance Without Overhead
Everything you need for approval and secure operations – already integrated: technology, documentation, hosting, and risk management.
Want to Learn More?
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
- Subscription model transparent, predictable costs with full scalability
- Scalability in focus from MVP to international rollout
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 manufacturing framework. You receive a finished product on our proven infrastructure – including development, operations, and regulatory assurance.
How quickly can I go live with my digital product?
Approximately 3 months from kick-off to completion of product development including CE marking for Class I and IIa. A lifestyle MVP can be CE-ready in about 8 weeks. Pre-validated components reduce development time by up to 80%.
How does the pricing model work?
One-time setup fee + monthly subscription fee. Minimum term of 12 months. Hosting, maintenance, compliance services, support, and further development included.
Compliance & Certification
Who assumes the role of Legal Manufacturer?
Either you or our certified regulatory partner. Both paths are supported by complete MDR-compliant documentation and ISO 13485-compliant processes.
Does the mHealth Suite cover all regulatory requirements?
Yes. MDR, DiGAV/DiPAV, BSI TR-03161, and BfArM data protection criteria. Additional features such as ePA integration or Health ID available on request.
After Launch
What does DUX Healthcare handle after launch?
Hosting, compliance maintenance, release management, monitoring, and further development – all covered by the subscription fee.
Can I add features later?
Yes. New features, indications, or content – without jeopardizing CE certification. Custom features are fully integrated.
Scaling & Flexibility
Is scaling to additional indications possible?
Yes. The modular architecture enables straightforward adaptation for additional indications. Existing documentation is reused.
Contact our experts