Medical Technology
Medical technology is evolving rapidly, becoming more digital, data-driven, and software-based. Connected devices, cloud platforms, and data-powered services are reshaping the industry, while expectations for security, interoperability, and lifecycle management continue to grow.
We design and develop scalable, secure, and regulatory-compliant software solutions for MedTech manufacturers, supporting the entire journey from the initial product concept to stable global operation. By combining technological excellence with regulatory expertise, we deliver digital medical products and platform solutions that make a lasting difference.
Developing Digital Medical Products
We build the next generation of connected MedTech software end to end, customized and scalable. From embedded systems to web and cloud applications and mobile solutions, we guide you through the entire product lifecycle: discovery, architecture, development, quality assurance, launch, and operation. We design Software as a Medical Device (SaMD) and Medical Device Software (MDSW) as well as complex software for active medical products and connected medical devices.
Our development processes align with regulatory standards such as IEC 62304 (Medical Device Software Lifecycle) and follow security by design principles according to IEC 81001-5-1 (Health Software Security). Clear software architecture, structured verification and validation, and end-to-end traceability create the foundation for approvals according to MDR and international regulations.
Your benefits: Faster time to market for SaMD or MDSW, robust architecture, and sustainable scalability in regulated markets.
Modernizing Software
Existing software systems are essential for long-term business success, but they are often technologically outdated or lack a modern look and feel. We help you make your applications future-ready.
Through structured assessments, we analyze architecture, security, performance, and maintainability, especially regarding IEC 62304 compliance, cybersecurity requirements under IEC 81001-5-1, and the interoperability of connected medical devices. Based on these insights, we develop a cost-efficient modernization strategy including a roadmap, cloud migration concept, and UX optimization where appropriate. Security and compliance aspects related to MDR, IVDR, FDA, and international approvals are systematically addressed.
Your benefits: Higher performance, improved usability, secure architectures, and measurable business value.
Connecting Systems and Products
Modern medical products are part of digital ecosystems. We implement secure and scalable solutions for connected medical devices, for example IoMT, SaMD, and cloud-based service architectures.
We integrate medical standards such as HL7 FHIR, DICOM, IHE, and SDC (IEEE 11073) to establish reliable data flows between devices, embedded software, backend systems, and cloud platforms. We ensure data integrity, privacy, and cybersecurity in line with IEC 81001-5-1 and other regulatory requirements.
The result is interoperable and secure architectures that enable remote monitoring, digital services, data-driven business models, and international scaling of medical device software.
Your benefits: Secure device connectivity, high-quality data foundation, and new digital service potential.
Platforms and Smart Ecosystems
Digital MedTech companies today think in terms of platforms, data spaces, and partnerships. We help you define a clear vision and a resilient platform strategy. From architecture and data principles to scalable cloud, hybrid, or on-premise architectures, and the integration of products, partners, and digital twins, we create the technological foundation for data-driven services and new business models.
Through modular platform architectures, we enable reusability, versioning, secure updates, and long-term maintainability, which are key success factors for global approvals and continuous innovation in medical device software.
Your benefits: Scalable platforms, sustainable innovation capability, and the creation of digital value networks.
Digital platform for networked cancer therapy
We have developed a digital platform for cancer therapy that seamlessly connects doctors and pharmacies. AI ensures structured, verified therapy data instead of manual processes. This saves time, reduces risks and improves the care of cancer patients.
Don’t hesitate to reach out to us.
Fabiola Hartung-Linz
Business Development Manager MedTech