Medical Software Engineering
We develop software for your medical devices in application areas such as intensive care medicine, cardiology and surgery. We create the technical documentation you need for approval in your target markets.
We develop software for your medical devices in application areas such as intensive care medicine, cardiology and surgery. We create the technical documentation you need for approval in your target markets.
Expertise 'Medical Software Engineering'
Innovation through Software
Software is a central component of medical devices and enables innovative solutions for diagnosis, therapy and monitoring. Development and maintenance of this software is complex and time-consuming due to rapidly developing technology and constantly changing regulatory requirements.
We support you in the implementation of medical innovations with our engineering expertise. This relieves you and allows your development team to focus on the core challenges. We contribute our experience from product development projects in various medical fields and procedures, e.g. extracorporeal circuits or electrophysiology.
How We Work In addition to defining the design input, we place great importance on intensive coordination with you at the start of the project - at what stage of the project do you need which results, e.g. for usability tests or submission to your notified body? How do we ensure prompt communication between all parties involved? Which toolchains do we use to avoid friction losses at a technical level? By clarifying these questions, we want to ensure that we work together efficiently.
Setting the Right Course A clear architecture makes it possible to make the software of your device easier to test, easier to maintain and easier for auditors to understand. This is why we break down the software into components before implementing the first functions. For example, we check whether we can use proven components to speed up development and verification.
Test Early, Test Often Small changes in software can have a big impact. That is why we strive for a high level of code coverage with tests that are executed automatically over and over again. To ensure that this also includes the important interface to sensors and actuators, we can set up a test system for your product and test the hardware 'in-the-loop'. This gives you certainty that your medical device will function as expected in the field even after a change.
Useful Documentation In approval processes or conformity assessments, auditors check whether normative requirements have been met during software development. In our work, we generate evidence in accordance with IEC 62304, IEC 81001-5-1 or FDA guidance documents. It is important to us that this technical documentation is easy to understand and clearly structured. This enables the auditors to carry out their checks quickly and the documentation facilitates software maintenance in the further life cycle of your medical device.
Concepts for Your Project Would you like to know how we can accelerate your project with our development expertise? Get in touch with us and let's get talking!
