Diagnostics  4.0

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
• Platform development
• 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

• Connecting devices: Interfaces, protocols, cloud connection
• 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
• Functional safety

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
• On-demand SOUP and tool validation services

Learn more about our sector-agnostic expertise in data analytics & artificial intelligence.

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

Find out more about medical consulting.