Functional Safety
We develop safe and secure software for your medical devices. We use our experience in the development of life-sustaining products and our knowledge of risk management, functional safety and cybersecurity.
We develop safe and secure software for your medical devices. We use our experience in the development of life-sustaining products and our knowledge of risk management, functional safety and cybersecurity.
Expertise 'Safety'
Safe Software for Safe Medical Devices
Reliable medical devices
Your medical devices must function safely and protect patients even under fault conditions. Clinical users rely on the reliability and safe function of your devices when they use them to diagnose, treat or monitor their patients. Notified bodies and regulatory authorities pay particular attention to compliance with legal requirements and safety standards during the evaluation process.
For these reasons, we implement an effective risk management process during software development so that hazards are avoided and risks are controlled.
How we work Risk management starts at the project planning stage. We create an interface to your risk management process in accordance with ISO 14971, because we want to understand the potential hazardous situations and you have the expertise to do so.
We take functional safety into account early on in the development process at the system and software architecture level. This enables us to find clear concepts that cover many risks with just a few measures.
Established methods Using methods such as FMEA or fault tree analysis, we analyze potential faults and work with you to agree effective risk control measures that reduce the risks to an acceptable level and enable first-failure safety in accordance with IEC 60601-1. To this end, we implement techniques from functional safety standards such as EN 61508 or implement alarm functions in accordance with IEC 60601-1-8.
Concepts for your project Do you have questions about requirements, implementation or verification in the area of safety? Get in touch with us and let's get talking!
