Description: While ISO 14971 establishes the framework for risk management across all medical devices, its application to in vitro diagnostic (IVD) devices presents unique challenges. Unlike traditional medical devices, IVDs rarely pose direct physical risks to patients. Instead, their primary impact lies in the accuracy and reliability of test results, which directly influence clinical decision-making and patient outcomes. This session will examine the complexities of applying ISO 14971 in the IVD context, including:
* Translating analytical and clinical performance data into meaningful risk assessments. * Addressing risks that arise from indirect harm, such as false positives, false negatives, or misclassification. * Considering workflow, human factors, and sample integrity in comprehensive risk evaluation. * Aligning risk management activities with IVDR expectations
Drawing on practical examples, the session will highlight strategies for bridging the gap between the general requirements of ISO 14971 and the specific realities of IVD product development. Attendees will gain actionable insights into building robust, compliant, and clinically relevant risk management processes tailored to diagnostics.
Learning Objectives:
Identify the unique sources of risk in IVDs compared to traditional medical devices.
Understand how to address risks that arise from indirect harm such as false positives, false negatives, or misclassification.
Tailor risk management strategies to IVD product development.
