Clinical Decision Support Software as a Medical Device

Clinical decision support (CDS) systems are usually developed to aid in the diagnostic and therapeutic decision for the individual patient. Thus, according to the present regulation of the European Union, this kind of software qualifies as medical device. In the last few years, Medexter not only recognized this development but adapted its software development process accordingly. Product development follows DIN EN ISO 13485 and includes concomitant risk analyses corresponding to DIN EN ISO 14971. Software documentation follows the standard specification DIN EN ISO 62304 and usability engineering that of IEC 62366. In 2022 two of our products—Momo and a system for the automated interpretation of laboratory test results—have already been certified as medical devices; others are under way to certification. The gained high competence in developing CDS systems according to medical device regulations enables us to accept outside orders for the customized development of CDS systems and have them certified as medical devices. We look forward to receive your orders!

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