Development of Software and Firmware for Medical Devices
Software and firmware are essential components of medical products, and due to ever higher requirements, they are becoming increasingly complex. Software used for medical purposes must meet high safety and reliability standards. Professional software engineering ensures efficient project implementation and continued success of your product.
We develop individual software and firmware solutions for your medical equipment. The spectrum extends from simple device control on a microcontroller basis to the development of complex embedded systems for various platforms such as Windows Embedded or Linux. We design attractive and specially optimized user interfaces and user workflows for medical technology. Our range of services extends to the entire process of software development, from analysing requirements and usability engineering to software development and testing to service and support, always in compliance with the applicable standards and regulations. We aim to ensure efficient project implementation and high quality through short distances and an optimal link between software development and system engineering.
Our software and firmware development services for medical devices:
- analysing requirements and requirement engineering
- identifying the applicable harmonised standards and directives
- usability engineering according to IEC 62366
- risk management according to ISO 14971
- development, verification, validation and documentation according to IEC 62304 and FDA requirements
- preparing the required documentation with respect to standards and regulations
- providing support during the approval procedure
- providing maintenance and support services for software and firmware