Features of risk´s management of hi-tech medical products manufacturing

[Summary form only given] Risk management system at the preparation and organization of medical product batch production is created with a view to ensuring, on the one hand, the maximum safety and efficacy (specialization of the application) of medical product, and on the other hand, extensive application, providing strong demand for this product and the minimum cost of the production. Feasibility study for a risk management plan includes the analysis of the identified risk sources, development and approval to a route and control methods at all stages of the technological cycle.