Medical

Growing ammounts of software with effective function and highest security

Today, software is an integral part of medical devices. Whether infusion pumps, dialysis machines or imaging devices such as computer tomographs, all share a growing proportion of software, both in the medical application, the HMI or the integration into a higher-level communication infrastructure.

It must be ensured at all times that this software is both effective in terms of the required function and safe for patients and does not lead to unacceptable risks.

The development of software for medical devices is faced with two fundamental tasks:

  • How can the complexity be kept to the necessary minimum and the software thus be kept maintainable, understandable and expandable?
  • How can the functional safety of the medical device software be demonstrated?

Axivion Suite offers solutions for both issues. With the architecture analysis, you can ensure compliance with your software architecture and also define safety and security architectures and monitor their compliance.

With the analysis of software projects according to metrics such as nesting or McCabe, key values of a high internal quality can be controlled. Additional security is provided by the coding guidelines for MISRA or CERT in order to quickly detect potentially unsafe program parts.

Our customers use Axivion Suite in projects with requirements according to IEC 62304 of all safety classes. The Tool Qualification Kit ensures confidence in the analyses of Axivion Suite in the customer environment.

Axivion Suite is available both on the developer’s workstation and in the CI / DevOps pipeline on the build server or in the cloud. This makes Axivion Suite part of your CI/CD strategy and quality assurance.

Many of our customers have safety requirements in their projects according to IEC 62304 from Class A to Class C. Our IEC 62304 solution integrates seamlessly into your safety process, from the configuration of the corresponding rules, the tool qualification kit to the reporting infrastructure.

Reference customers

Success Stories

A selection of our Success Stories from the medical sector