At Gateway Digital, we are committed to empowering healthcare providers in Europe, particularly Germany, with cutting-edge digital solutions. With extensive experience in DiGA app development and BSI certification , we ensure your healthcare apps meet all regulatory requirements, helping you navigate the complex healthcare ecosystem. Whether you are looking for end-to-end development or seeking expertise in compliance, our team is here to guide you through every step.
.png)
Value Proposition
Proven track record in Germany
We have successfully developed multiple DiGA apps that have been certified and launched in Germany. Our deep understanding of the regulatory landscape makes us a trusted partner for healthcare organizations across Europe.
Compliance Expertise
With a team of experts focused on the latest healthcare regulations, we provide unmatched guidance on BSI certification and DiGA compliance, ensuring that your app meets all necessary standards for successful approval.
Agile development approach
We follow an agile way of working ensuring flexibility and rapid delivery. This approach allows us to collaborate closely with clients and adjust quickly to changes, delivering high-quality apps that meet both functional and compliance needs.
Transparent communication
We believe in building strong, long-term relationships through transparent communication. Our clients always know where their project stands, and we provide clear updates at every stage of development.
Our Process
Requirement Gathering
We begin by understanding your specific needs, goals, and the regulatory requirements for your healthcare app. This helps us lay a solid foundation for the development process.
App Design and Development
Our design team creates user-friendly interfaces, while our developers ensure your app is technically robust and compliant with all necessary regulations.
Compliance and Certification
We guide your app through the BSI certification process, ensuring it meets all necessary standards for data privacy, security, and medical safety.
Deployment and Post-Launch Support
After successful certification, we deploy your app and provide ongoing support to ensure its smooth operation, including regular updates and user feedback integration.
Frequently Asked Questions (FAQs)
What is DiGA, and why is it important?
DiGA (Digital Healthcare Application) refers to healthcare apps that meet specific regulatory standards for use within the German healthcare system. Certification ensures that apps are safe, secure, and provide genuine healthcare benefits.
How does the BSI certification process work?
The BSI (Federal Office for Information Security) certification process ensures that your app complies with strict data protection, security, and quality standards. We guide you through documentation preparation, submission, and regulatory review.
What makes Gateway Digital different for DiGA development?
We specialize in the German healthcare market, offering deep knowledge of DiGA compliance and BSI certification. Our team’s expertise, agile development, and track record in the industry set us apart.
How long does it take to develop a DiGA-compliant app?
Development timelines vary depending on the complexity of your app. However, we typically deliver DiGA-compliant apps within 6 to 9 months, including BSI certification.
Do you provide ongoing support after the app is launched?
Yes, we offer comprehensive post-launch support, including updates, bug fixes, and help with maintaining compliance as regulations evolve.
Can you help with non-German healthcare markets?
While our primary focus is on the German healthcare market, we also have experience in European healthcare regulations and can assist with expansion into other markets.
Useful Resources
BSI - Technical Guidelines TR-03161
