Experts on market and technology specific topics (IVDR, MDR)
Pharmaceutical industry, in-vitro diagnostics, bioprocess technology, analytics or medical technology: Every industry has its requirements, work processes and special disciplines for which you as a device manufacturer, system integrator or laboratory operator are an absolute expert. As soon as you want to digitize and automate your workflows or offer your laboratory and medical equipment a decisive user added value via the software, we are your ace up the sleeve. We support you from software prototyping in device pre-development through digital work processes in the laboratory to standard-compliant software as a stand-alone application or as a component of certified medical and laboratory products. We are one of the few software service providers in Europe to have a certified quality management system in accordance with ISO 13485 and our own development process that meets all the requirements of IEC 62304 and other relevant standards. MDR-, IVDR-, FDA-, NMPA- and GMP-compliant software can therefore be developed flexibly according to your or our processes.