System Modeling
The Arcadia method offers a model-based approach for this, which is implemented in practice using the Capella tool in particular and allows a clear view of requirements, logic and physical implementation. In larger organisations, system modelling is often associated with enterprise architecture and can be carried out using tools such as MagicDraw (or Cameo Systems Modeler), for example to integrate SysML-compliant models into higher-level architectures.
Risk Management
- Hazard classification matrices and import structures
- Customised FMEA traceability reports
- Mapping of damage severity and integration of risk minimisation measures
- Structured templates for hazardous situations
- Advanced automation and scripting for real-time reporting
Cyber Security Engineering
You receive reliable products and solutions that have been developed in accordance with leading industry standards such as ISO 27001 and IEC 62443 and carefully tested for vulnerabilities.
Cybersecurity is integrated into every step of your process – from initial concept to final implementation – guaranteeing secure innovation from start to finish.
Hardware Engineering
Our team supports you in hardware requirements engineering – a systematic process for identifying, specifying, analysing and managing physical hardware requirements throughout the entire development cycle.
Software Engineering
We support you with software requirements engineering
The systematic process for capturing, analysing, specifying, validating and managing requirements for software systems. In doing so, we create a common basis for all those involved, be it developers, customers, testers or project managers.
UIUX & GUI Engineering
We offer UI/UX requirements engineering as a specialised discipline within software requirements engineering and ensure that user interactions are guided by clearly defined design and usability principles.
To support consistent and targeted implementation, we develop and use comprehensive style guides that translate your corporate identity (CI) into uniform visual and linguistic standards.
Standards
Management
In the regulated medical environment, our standards management ensures that all requirements, risks and tests are seamlessly linked to applicable standards such as ISO 13485, ISO 14971 and IEC 62304.
With Polarion ALM, we create complete traceability – from the clause to the design. In this way, we support our customers in realising safe, compliant and auditable systems.
Polarion
Customisation & Extensions
Our team offers customised Polarion adaptations to tailor the platform to your specific workflows
Improving traceability, collaboration and efficiency throughout the development cycle. In addition to comprehensive customisation services, we also develop our own extensions – such as our intelligent requirements sentence template – that simplify specification creation, ensure consistency and accelerate project delivery.
Test Management
In the context of medical technology development, Polarion ALM enables a structured and traceable approach to test management.
Userneeds, UseCases & Usesteps
The UseFMEA is used to analyse user-centric failure modes of the modelled use steps in a structured way.
- The assignment of use steps to hazards and failure modes,
- the identification of errors in perception, thinking and action,
- as well as linking each use step with risk minimisation strategies.