Software as a Medical Device

To certify a software as a medical device holds many chances for the manufacturer, but at the same time increases the complexity of the project. If it is software development or support on subareas: We are your experienced partner for software projects that comply with the law and relevant regulations.

Requirements Engineering

Solid requirements engineering is essential for the success of a software project. To do so, we first create a well-founded context analysis and, on this basis, design convincing user stories that flow hand in hand with the stakeholder requirements into the application structure. In several design sprints, a prototype will then be created before we move on to the actual development. »Contact us.

Software development as medical device

We build the bridge between agile and standards-compliant software development. Based on the previously developed prototype, we create a well thought-out system and software architecture and approach the first real-life version sprint by sprint - while strictly adhering to the specifications of EN IEC 62304 for the software life cycle and EN IEC 62366 for usability. »Learn more.

Managed Hosting and Cloud Services

We ensure the operation of your medical device application, either in our own TWT DH cloud or on the cloud server of your choice. Our concepts for the storage and processing of health data, IT security solutions and managed applications are tested and proven in practice. »Learn more.

Risikmanagement

In accordance with the general requirements of MDR, we check software concepts for unrecognized hazards, evaluate the risks and develop control measures. Among other things, we create the Failure Mode and Effects Analysis (FMEA) and carry out a data protection impact assessment. »Contact us.

Placing the software on the market

With our certification according to DIN EN ISO 13485 we are qualified to bring your software, which is classified as a medical device, to the market. »Learn more.

Software-Lifecycle Management

Software Lifecycle Management includes the aforementioned aspects as well as the downstream phase and the maintenance of an application. We monitor and observe the market with regard to technical and legal changes and carry out a new risk assessment at least once a year. In case of deviations or malfunctions, we implement the necessary adjustments promptly. At the same time, we keep the application up to date at all times. »Contact us.

Consulting

We are eager to share our knowledge from numerous medical software projects with you: We accompany you through the entire process of developing software as a medical device, starting with the formulation of the intended use, the choice of conformity assessment and the establishment of a quality management system according to DIN EN ISO 13485. »Learn more.