This chapter provides an overview of the development Phases involved in transforming a technology originated in research into a medical product for commercialization. It first describes the four main Phases, from the emergence of the need for the product to its post-marketing obligations. It is intended to help the interested reader understand the stages, documents, guidelines, and regulations that a medical device must go through in order to be marketed. Special highlight is given to the necessary topics that must be addressed in order for the device to be certified. Every product that goes to market must be certified by some regulatory body in order to ensure that it will not cause any negative impact on its users. Further, for medical devices, these requirements are heightened, as they may come in contact with the user, potentially causing a direct risk to them. Thus, reading this chapter will provide the reader with an understanding of these Phases within the industrial environment as well as the aspects that must be taken into account before placing a medical device on the market.

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Technology Transfer: From Research to Industrialization

  • Aline Santos Silva,
  • Ana Sofia Cacais do Carmo,
  • Hugo Plácido da Silva

摘要

This chapter provides an overview of the development Phases involved in transforming a technology originated in research into a medical product for commercialization. It first describes the four main Phases, from the emergence of the need for the product to its post-marketing obligations. It is intended to help the interested reader understand the stages, documents, guidelines, and regulations that a medical device must go through in order to be marketed. Special highlight is given to the necessary topics that must be addressed in order for the device to be certified. Every product that goes to market must be certified by some regulatory body in order to ensure that it will not cause any negative impact on its users. Further, for medical devices, these requirements are heightened, as they may come in contact with the user, potentially causing a direct risk to them. Thus, reading this chapter will provide the reader with an understanding of these Phases within the industrial environment as well as the aspects that must be taken into account before placing a medical device on the market.