PrehApp GmbH
As a manufacturer of medical software, we develop digital health applications together with specialists from medicine, sports science and physiotherapy to close gaps in care.
We bring products to life individually, precisely and with a patient-centred focus, from the first idea to the operation of your digital medical device, all from a single source!
We discuss your idea with you and, together with our team of experts, develop a tailored concept. In doing so, we take all regulatory requirements into account and ensure an optimal user experience for patients.
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.
We manage the conformity assessment procedure in close cooperation with notified bodies and ensure that the medical software obtains CE certification. We draw on our extensive experience from our successes in DiGA development to implement all regulatory requirements professionally. With partners, we also support the organisation of clinical studies and the submission of required applications, and we handle communication with the competent authorities.
We monitor the medical device on the market and are responsible for its safe operation. We also take care of the upkeep and maintenance of the digital medical device to ensure smooth functionality. In addition, we ensure that all medical data is hosted exclusively in the EU to meet the highest security and data protection standards.
