Devices

CDRH Learn Module on Quality Management System

A CDRH Learn education module presented by Postmarket Industry Education Team assistant director Tonya Wilbon covers the Quality Management System Regulation (QMSR) with its requirements for risk management, a risk-based approach, and risk-based decisions. The module defines essential risk terms; explains the role of risk management within the broader Quality Management system; identifies the QMSR requirements for risk management, risk-based approaches, and risk-based decisions; and reviews examples of risk documentation.

Risk management is defined by the American National Standards Institute, Association for the Advancement of Medical Instrumentation, and the International Organization for Standardization as the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk. That definition is included in their ISO 13485 standard that FDA has acknowledged in its QMSR final rule.

The module says risk management helps identify, assess, control, communicate, and review medical device risks to the quality management system processes. “It provides reasonable assurance of safety and effectiveness throughout the total product lifecycle,” it says, “from design and development through postmarket surveillance and eventually discontinuation. Risk management provides a framework for sound decision-making within a quality management system.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome