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With groundbreaking progress in science and the constant evolution of medical devices, the importance of secure software in the medical industry has skyrocketed.
Software failures, delays and ultimately, the possible threat of losing lives, are not acceptable in a safety-critical environment. Axivion can help you prevent this through reliable static analysis and architecture checking.
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 as well as 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.
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.
The development of software for medical devices is faced with two fundamental tasks:
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.
Many of our customers have safety requirements in their projects according to the IEC 62304 standard from Class A to Class C. Our tools integrate seamlessly into your safety process, from the configuration of the corresponding rules, the tool qualification kit to the reporting infrastructure. Axivion Static Code Analysis is even certified by SGS-TÜV Saar GmbH for use in the development of safety systems according to IEC 62304 standard up to Class C.
The Axivion Tool Qualification Kit ensures additional confidence in the analyses of the tool in the customer environment. Axivion is available for use on the developer’s workstation as well as in the CI / DevOps pipeline on the build server or in the cloud. This makes Axivion part of your CI/CD strategy and quality assurance.
Functional safety in medical device software is not a game. It sometimes decides about life or death. Axivion Suite and its extensive set of features help you fulfil not only the IEC 62304 standard but also many other relevant guidelines, directives and regulations for developing software of the highest safety standards.
Read what our customers have to say. Learn more about the benefits of integrating our Quality Assurance products into your software development process.
"Thanks to the support during implementation and the excellent support provided by the Professional Services Team, it proved possible to integrate the Axivion Suite into our development environment quickly and easily. There are virtually no architecture violations now; instead, we have a higher standard of architecture-compliant code – across all our development teams, worldwide."
Siemens Healthineers
“Thanks to the Axivion Suite, we have the maintainability of our software under control, thereby safeguarding our long-term capacity for innovation.”
Thomas Stahl
Director Software Engineering, Fresenius Medical Care
“The Axivion Suite provides us with vital support in ensuring our software quality. Its checks are not merely driven by existing standards, they even exceed the required level.”
Dentsply Sirona
We support you in any use case or requirements you may have and provide a reliable solution for you.
Get a free demo or apply for our strongly recommended Proof of Value Workshop or just ask your questions. We´re here to support.
Read more success stories, watch webinars and download documents for Squish, Coco, Test Center and Axivion.
Visit QA Resource CenterOur tools support every stage of product development and facilitate continuous improvement, sustainable maintenance and of course functional safety.
Learn more >Ideal for safety projects according to IEC 62304. It is certified to assure your software quality and supports you in achieving the required tool confidence level (TCL).
Read moreQt Group includes The Qt Company Oy and its global subsidiaries and affiliates.