Your one-stop shop for digital health applications and medical apps
Your ideas for innovative medical products are helping to move healthcare towards a bright digital future. As your ISO 13485-certified engineering partner, we are here to help you put these ideas into action. We overcome regulatory hurdles and fast-track your time to the healthcare market with standards-compliant development.
Partners on the path to your medical product
When it comes to developing medical devices, there is no such thing as an off-the-shelf solution, yet predeveloped components can be used when systems integration and verification are assured. That’s why our proven Digital Health Microservices Platform is the go-to solution for your tailor-made health applications. It bridges the gap between health data and digital health applications, and we will combine and tailor our services flexibly to your specific requirements.
Our services
Digital health solutions
Our support is all yours, at every step of your efforts to develop embedded software, desktop and mobile applications, digital health applications (DiGA), and wearables. Our top priority, first and always: your medical product’s approvability and usability. Call on us for
Standards, rules, regulations: The medical industry certainly has plenty of challenges in store for new digital health solutions. As a certified partner, we have the expertise to accompany you from the very beginning through to approval – from concept development and the establishment of a quality management system to risk management and development. Count on us to support your product’s launch on the healthcare market. We can help you with
Requirements and systems engineering
Usability/ workflows
Regulatory affairs
QMS according to ISO 13485
MDR compliance
Risk management according to ISO 14971
Usability according to IEC 62366
Legal manufacturer issues
Connectivity and cyber security
Connected devices on the Internet of Medical Things and artificial intelligence present many unprecedented possibilities, but they are also vulnerable to cyber attacks. Drawing on our device connectivity skills and functional and cyber security expertise, we make sure your medical product is protected. Our specialists team up with yours to develop a holistic, security-by-design concept to guard your systems against cyber attacks. We know all about
Sensors
Data transmission via cloud connectivity, Bluetooth, and the like
Interfaces to HIS / PACS / EMR / LIMS
Security risk assessment
Basic security concept
Penetration testing
ISO 27001 requirements
Learn more about our cross-sector skills in cyber security.
Market surveillance and operations
As your one-stop supplier, we support you throughout the development process – and even beyond to encompass operations, post-market surveillance, and maintenance. Count on our
Proven hosting concepts
Risk analysis updates
Software updates, e.g. in the area of security
Digital health applications (DiGA)
When we set out to develop digital health solutions, we do it with a passion for innovation, laser-like focus on results, and lean but standards-compliant processes. Cyber security, data protection, and regulatory issues are on our minds from day one. We offer
Conceptual design and consulting services
MDR-compliant implementation and documentation as an ISO 13485:2016-certified partner
Highest security standards according to DiGAV
GDPR -compliant implementation
Usability and accessibility
Proven hosting concepts
Fast, microservice-based implementation
Support during the approval process
Expertise
App on prescription
Digital health applications are apps as a medical device. In Germany, doctors can prescribe these apps to their patients if they are listed in the DiGA directory. The requirements for listing are stringent, so these have to be considered during development from day one.
Gynecology consultation. Doctor working on computer
Success Story
Flexible and secure into the cloud
What does it take to make complex system architecture for a medical device highly scalable, flexible, and secure? A digital health startup asked us to develop a modular microservice infrastructure that can be hosted on-premises or in the cloud. We delivered the goods.
Securely connecting medical devices and leveraging data potentials
Connected medical devices provide a wealth of operating data for analysis. They serve to collect, evaluate, and exploit specific data for a wide range of use cases. These data are not only a boon for device manufacturers; they are also a must-have for post-market surveillance as the requirements for this monitoring have become far more stringent since the MDR came into force. So how can medical devices be securely, and what can and cannot be achieved with the help of data analytics?
A digital success story in the healthcare market From consulting and development to certification
When we set out to develop digital health applications, mobile medical apps, and the like, we do it with a passion for innovation, laser-like focus on results, and lean but standards-compliant processes. As your engineering partner for digital health innovations, we take cyber security, data protection, and regulatory issues into account right from the start. This way, nothing will deter your successful market launch.
