Risk assessment system in the production process of medical devices on the basis of dynamics spine corrector

Abstract

The article presents the methodology involved in creating a risk analysis of medical devices. General regulations contained in the PN-EN ISO 14971 provide manufacturers of medical basis for the concretization of standards in the form of risk assessment system for a particular process and product. However, there is no top-down regulations defining the level of acceptable risk and the decision to determine its value rests with the manufacturer. Effectiveness of taken measures was tested on the example of a analysis of dynamics spine corrector – medical device that is allowing independent rehabilitation under the supervision of a physiotherapist and current control of the kinematics and dynamics of the human spine