Good practices systematization for medical equipment development and certification process: A Brazilian case study

Abstract Medical equipment development requires from manufacturers a clear definition of the processes to the core team in order to achieve the user safety. Therefore, considering the lack of a specific product development framework for medical equipment that meets the Brazilian scenario, this work proposes a good practices systematization for medical equipment development. It covers the main Brazilian regulations that impact on development process of these products. Based on the stage-gates process, the systematization proposed divides the development process activities into five phases and nine functional groups. To each functional group is presented the activities expected to be practiced in each phase, tools that could be used, and the regulations that could guide the execution of the activities. The case study method was used to validate the systematization. Three companies of medical devices were presented to the model and their realities of the development process were compared to the proposed systematic. From the results was possible to conclude the potential use of the good practices as a guide for the process development of health equipment. Besides that, the model allows to follow up the regulations that should be used and can be used as training material.

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