CONZE Informatik GmbH has been certified according to DIN EN ISO 13485:2016 for the development of medical software in February 2023. Thus, the company from Siegen is one of a few in South Westphalia that has the qualification and legal approval to produce highly critical software.
In many cases, a crash or failure of medical devices such as defibrillators or ventilators is life-threatening. Accordingly, the requirements for these safety-critical medical devices are also high. The European regulations on the development of medical devices (MDR) and in vitro diagnostics (IVDR) ensure that all safety regulations are complied with in the manufacture of medical software, thus guaranteeing the highest quality.
Since its foundation in 2009, CONZE has been developing software with a focus on robust and performant user interfaces. In 2016, the company's quality management system was certified according to DIN EN ISO 9001:2015. The new DIN EN ISO 13485:2016 certificate now opens the doors for customers from the medical technology, healthcare, pharmaceutical, rehabilitation and fitness industries. The legally prescribed requirements can thus be met more efficiently. This formal qualification allows the IT company to look forward to new projects with excitement. For example, CONZE's team implements custom embedded software, desktop applications, cloud services, mobile apps and digital health applications (DiGA) for international clients. Perhaps the software for your next CT, MRI or ultrasonic device will come from South Westphalia.