What is the primary focus of the risk management process in regulatory affairs?

The primary focus of the risk management process in regulatory affairs centers on assessing potential hazards associated with devices. This process is critical as it involves the identification, analysis, and control of risks that could adversely affect the safety and efficacy of medical devices and pharmaceuticals. By systematically evaluating the risks, regulatory affairs professionals can develop strategies to mitigate those hazards, ultimately protecting patients and ensuring that products meet safety standards before and after they reach the market.

Identifying manufacturing defects, ensuring compliance with regulatory standards, and evaluating customer satisfaction are important aspects of a company’s overall operations, but they are not the core focus of risk management in the context of regulatory affairs. While these factors may be influenced by the findings from risk assessments, they do not directly address the systematic approach needed to identify and manage risks associated with a product's lifecycle, which is vital for regulatory compliance and product safety.