Consulting

If you have a bold idea, we are the right partner to test it with. Our flexible and powerful platform allows us to test initial ideas quickly and explore different ways to solve your challenge. Within a few weeks, sometimes even days, you’ll have an interactive prototype to explore, test, and develop further with us.

Where needed, we combine technical expertise with experience across clinical applications to refine the requirements and clarify the problem to be solved. We identify key risks and shape a practical development strategy before committing to full-scale development.

We turn validated concepts into product ready medical imaging software. This covers custom algorithms, AI integration, implementation, system integration, and deployment. Because our early prototypes already use our product-grade platform, you can move from research into development without a separate technology handover or complete rebuild. Our engineering teams create reliable and maintainable products through strong software architecture, testing, and performance optimization.

We provide consulting on training data requirements and preparation, access to in-house datasets that can be combined with private data, and a complete toolset for efficient image annotation and dataset creation.

If needed, we design custom model architectures for specific requirements and train these models on our own compute cluster.

All models are delivered ready for integration and can be deployed on edge devices or in the cloud for efficient real-time inference. We also optimize compute requirements for target hardware and support integration into existing applications and workflow

We deliver comprehensive technical documentation aligned with IEC 62304, ISO 13485, and ISO 14971 standards, including requirements, risk analysis, verification reports, cybersecurity assessments, SBOM and traceability matrices ready to be included in the product technical file for CE marking and FDA submissions.

We perform risk management and cybersecurity analysis as part of the regulatory process, helping teams prepare documentation required for CE marking and FDA submission. This includes providing an SBOM, screening for cybersecurity vulnerabilities of all software components used and assessing impact when vulnerabilities are discovered.

We provide structured reporting for AI/ML models and support documentation required for regulatory submissions. This includes documentation of technical model parameters, such as architecture, hyperparameters and training splits, as well as information on data sets used for training including sources, patient population and other relevant clinical statistics. In addition, we support in the data annotation process and provide compliant tooling enabling our customers or annotation companies in creating properly annotated and documented ground-truth data for training and validation. We also support our customers in sourcing additional compliant training data for their projects.

In addition to the services directly linked to our software, our team of regulatory experts also supports our customers on general regulatory questions, for instance for device classification, regulatory strategy, PMS and other topics.

Our software supports Windows, Linux, and macOS environments, allowing teams to integrate imaging workflows and applications into existing development ecosystems.

Embedded platform support (e.g. NVIDIA Jetson ARM) is available on request. Our team can support deployment and integration for projects requiring embedded hardware environments.

We support integration with ultrasound devices, tracking systems, robots, and navigation technologies. Our software provides interfaces to a wide range of imaging and hardware systems used in medical applications.

We help prepare your product for reliable deployment in its intended clinical and technical environment. This includes system integration, configuration, packaging, and resolving practical issues that emerge during rollout.

After the release of a certified medical device product into the market and for it’s entire active sales and post-sales lifecycle, we are supporting our customers with continued pro-active screening for cybersecurity vulnerabilities, providing impact assessment and bug fixing. We also support in post-market surveillance activities, reviewing data from the field within the scope of patient privacy compliant data processing agreements and, if needed, fine-tune or re-train models. We also support our customers with respect to new regulatory and legal changes in AI, cybersecurity or other fields related to our software and provide updates to keep compliant.

We continue supporting your product through bug fixes, performance improvements, and compatibility updates. Our team helps keep the software reliable as operating systems, hardware, and connected components evolve.

We help extend established products to new devices, clinical applications, and deployment environments. Building on the existing platform allows new capabilities to be added without starting again from scratch.