We create customized, targeted, and patient-centered products—from the initial idea to the operation of your digital medical device, all from a single source!
Our services:
Consulting & design
We discuss your idea with you and develop a customized concept in collaboration with our team of experts. In doing so, we take all regulatory requirements into account and ensure that an optimal user experience is guaranteed for patients.
Software development
We develop your medical software in compliance with IEC 62304 and ensure that risk management, data protection, quality assurance, and usability meet current standards. We offer comprehensive services for the entire software development process.
Regulatory affairs
We manage the conformity assessment process in close cooperation with notified bodies and ensure that the medical software receives CE certification. We leverage our extensive experience based on our success in DiGA development to professionally implement all regulatory requirements. In addition, we work with partners to organize clinical trials, submit the necessary applications, and handle communication with the relevant authorities.
Software maintenance
We monitor the digital medical product on the market and are responsible for its safe operation. We also take care of the maintenance and servicing of the digital medical prdouct to ensure smooth operation. In addition, we ensure that all medical data is hosted exclusively in the EU in order to comply with the highest security and data protection standards.