As your engineering partner, we are here to expedite your efforts to develop standards-compliant diagnostic solutions for the laboratory, point-of-care, and home care. To this end, we draw on innovative technologies and methods, and take a big-picture view that extends beyond the application to encompass risk management.
Together we make diagnostics even smarter!
One great challenge in diagnostics is to accurately analyze vast amounts of data. The other is to deliver the results quickly and securely to where they are needed. #Automation and #digitalization help to make reliable diagnoses and communicate them target-oriented – in medical practices, labs, hospitals, research facilities, and wherever patients happen to be. With nearly 30 years’ experience as a software and systems development partner, we have broad knowledge in this exciting and dynamic arena.
Standards-compliant development of diagnostic solutions
As an ISO 13485-certified software and system development partner of long standing, we support you by pursuing a standards-compliant approach to throughout the development cycle, from the feasibility study to the finished product. This is how we clear every obstacle on your path to certification (IVDR/MDR, FDA). Once your product is certified, we can stay on board to provide maintenance and support to help keep it on the cutting edge. Call on us for
Product development and maintenance according to ISO 13485, information security according to ISO 27001, risk management according to ISO 14971, software development according to IEC 62304, usability engineering according to IEC 62366, system, hardware and mechanics development according to IEC 60601/IEC 61010
Requirements engineering and concept studies
Product maintenance services and support (updates, security monitoring)
Application lifecycle management tools to ensure full traceability
Model-based development, agile development with SCRUM, DevOps, and continuous integration
We connect your IVD devices to ensure information is accessible at every need-to-know point, with cyber security and data protection assured. Last but not least, this is relevant for post-market surveillance. We can enable
Connections to HIS/PACS/LIMS/EMR systems: HL7/DICOM/IHE/FHIR standards-compliant integration, communication, and data transfer
Remote access for device status (and for traceability), remote diagnostics, remote maintenance/ updates, predictive maintenance, licensing, post-market surveillance surveys, and evaluations
AR/ VR: Projected/ displayed information and simulations for service, maintenance, and training
Consideration of cyber security, information security, and data protection (GDPR)
Our experts know how to automate everything from routine tasks to complex workflows. Let us join forces to develop automated solutions for your analytics workflows. And our skills in control engineering, sensors, robotics, signal and image processing, and machine learning can greatly benefit your efforts to design intelligent diagnostic systems. Let us help you with
Robotic automation systems
Control technology incl. sensors
Embedded and real-time systems
Data science & analytics
Connected diagnostic devices provide a wealth of operating data for analysis. Our data science, analytics, and machine learning methods can help you put your data strategy into practice. We offer
Predictive analysis, profiling, monitoring, and more to help put your vision into action
Advice on technologies’ capabilities, limitations, and approvability
Ways to factor the regulatory framework, certification, and risk and data management concerns such as anonymization into the equation
Methods, algorithms, and tools for the given application and data quality
Data processing and data harnessing in ways that let you make the most of your data sets
Process-based (AI) development services encompassing implementation, learning, model verification, and documentation
You can count on our assistance to manage regulatory affairs, digital processes, and tools. With so many years’ experience developing diagnostic and medical devices to our credit, we can provide directions at the crossroads of regulations and technological development., including risk management. We provide
Consulting on IVDR/MDR and 21 CFR Part 820 and Part 11
QM/QA systems implemented and optimized in compliance with ISO 13485
ISO 14971-compliant risk management
IEC 62304-compliant software development
SOUP, COTS software, and tool validation with risk-based, efficient methods
State-of-the-art cyber security delivered
IEC 62366-compliant usability engineering services, coordinated with the development and risk management process
Advice on how ALM tools can support digital processes
Polarion ALM medical modules, including configurations and templates adapted and implemented to suit your processes and specifications
Guidance on how to choose and pursue the right development approaches (agile methods, DevOps) in the regulated area
How do you efficiently monitor a multitude of devices with complex functions? We developed a customer-specific software solution for laboratory equipment that enables intuitive management and execution of measurement and control tasks on a modular user interface.
These days, laboratories have a great responsibility to rapidly analyze samples and expediently deliver results. The key to managing complex processes, optimizing workflows, and boosting efficiency is to digitalize and automate diagnostics.
Detecting anomalies in ECGs with the help of artificial intelligence
Joining forces with Hacarus, a Japanese start-up, we developed a proof of concept for a personalized patient monitoring system serving to evaluate ECG signals. This system not only detects abnormalities in real time; it also enables comparisons with what would be expected to be a normal curve.
Automating and digitalizing diagnostics System development from a one-stop shop
Embedded laboratory devices, robotic assistance systems, portable POCT products, remote patient monitoring devices, digital diagnostics – we provide the full range of software and system development services for a wide range of platforms. And all this is delivered to you from one trusted source. Let us jointly take diagnostics to a new level.