In the context of medical technology, what does "risk management" involve?

Risk management in the context of medical technology specifically involves the identification and prioritization of risks associated with medical devices. This process is crucial because medical devices can pose various risks to patients, healthcare providers, and institutions. Effective risk management entails a comprehensive analysis that allows manufacturers and regulatory bodies to identify potential hazards, evaluate the likelihood and impact of these risks, and implement appropriate measures to mitigate them.

By prioritizing risks, stakeholders can allocate resources appropriately and ensure that safety measures are in place during the design, manufacturing, and post-market phases of a device's lifecycle. This focus on risk assessment helps to protect patients and enhance the overall quality and safety of medical technology. It is a foundational component of regulatory compliance and best practices in the medical technology field, ensuring that devices perform safely and effectively in real-world settings.