ENSoftware is becoming increasingly important and pervasive in healthcare. Deads and injuries, recalls related to the medical software, defective medical device statistics justify the practical dimension of the issue and needs to search ways seeking reduce possibility to arise injuries and deaths. Decision to release medical software to the market is very important not only to the manufacturer (design and development organization), but also for direct and indirect users (doctors and patients) and for all society, which is using national medical system with integrity information technologies possibilities. Manufacturers of medical devices assume responsibility for the correct functioning of medical devices and medical software manufacturer should assume responsibility for medical decisions making and medical decision influence on patient. This responsibility is related not only to the legal and financial risk, but also to the socially responsible business commitments. Software developing companies does not have knowledges about the conditions, which can assure medical software confidence before the release to the market. Such situations stops entrepreneur involvement in the medical software creating area. [From the publication]