Tag Archives: ISO 14971

Risk Management in Medical Devices: Harmonizing ISO 14971-2019 & FDA QMSR

By Prasad Ravichandran 

nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.

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