Your one-stop shop for digital health applications and medical apps

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-compliant development and documentation
• Front-ends/ back-ends/ apps
• Software, hardware,mechanics
• Embedded and real-time systems
• Verification and validation
• Prototyping
• User-driven UX / UI, usability engineering (IEC62366)

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

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.

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

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