Medical devices represent hope for a better future, living quality and longer life, improving our life quality and supporting wellness, and providing more and more drug-free remedies at each new development stage. Despite continuous research in the medical field and technological as well as industrial development developers and engineers facing more and more challenges in medical device engineering. And there is one more challenge - new products and new technologies bringing new risks, that's why so important to design medical devices with risk mitigation for patients and the project's budget. During the development process, we follow robust specifications and standards such as ISO13485, IEC 62366, ISO/IEC 15288 and some others, this brings us better design results quality, well-prepared documentation and reduce project risks as well as lets us correspond to all checklists and requirements.