• Feature ArticlesFeature Articles

    Medical Device Risk Management

    This article focuses on risk management in the medical device industry and reviews organizational competencies, processes and resources as well as beliefs and behaviors. The authors conclude that, especially in the later phases of product development, not enough attention is paid to risk management tools. Introduction In our previous article, "Organizational Culture and Memory in Managing Risk in the Medical Device Industry" ( Regulatory Focus, August 2017), we discuss...
  • Feature ArticlesFeature Articles

    Organizational Culture and Memory in Managing Risk in the Medical Device Industry

    This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality." Introduction According to the Italian Renaissan...