Risk Management in Medical Device Industry

Abstract

In spite of the fact that risk management has developed into an essential component of the process of developing medical devices, as mandated by both domestic and international regulations and standards, there is still no all-encompassing model that describes how risk management in the development of medical devices ought to be approached, particularly in terms of the types of risks that ought to be addressed. This is due to the fact that risk management has developed into an essential component of the process, which is mandated by both domestic and international regulations and standards. The present focus of risk management in the industry of developing medical devices is on technical risks, such as product, usability, and development process hazards. This is done in compliance with the norms and laws of standards. On the other hand, non-technical risks, such as those associated with businesses and projects, are not given nearly enough consideration. This review focuses on the risk management in medical device industry.