The United States Food and Drug Administration (US FDA) released the highly anticipated revised Quality Management System Regulation (QMSR) in February 2024. The updated regulation serves as the new set of Good Manufacturing Practices (GMP) guidelines of the US FDA for medical devices, effectively replacing the previous set of Quality System Regulations (QSR). The US FDA QMSR now aligns more closely with the ISO 13485:2016, the international standard for medical device Quality Management System (QMS).

Risk management is a critical activity across all phases of the medical device lifecycle as it directly affects the safety and well-being of patients. Risks are unavoidable; however, they can be curtailed if companies are aware of impending hazards and follow effective risk management procedures.

Risk management is an essential process for medical devices to ensure their safety and effectiveness. Medical device manufacturers must have established risk management processes to combat and reduce the risks, by performing thorough risk evaluations. Though there is no sufficient real-world data to accurately quantify risks, there are effective and systematic steps, which can be established by the manufacturers, to analyze, evaluate, control, and mitigate risks. Let us understand what these steps are and how will they aid in medical devices risk management.