Streamlining medical device design development process from research laboratory to the market

Abstract

The objective of this paper is to describe the common conformity assessment procedures to comply with the regulations in certifying devices for medical use. This paper also defines the main aspects of medical devices in general with common key differences between medical devices and consumer products. Furthermore, this paper highlights the role and importance of literature research in medical device development, particularly in shortening the time-to-market and in the certification process. Finally, this paper gives the researchers of institutes and universities suggestions on what could be taken into account at the very early phase of ideation of possible methods and products that are intended to be classified as a medical device.