What is ISO 14791:2018

ISO 14791:2018 is a technical standard that provides guidance for the application of risk management to medical devices. It outlines the requirements and principles for developing, implementing, and maintaining a risk management process throughout the life cycle of a medical device.

Scope of ISO 14791:2018

The scope of ISO 14791:2018 is to establish a common understanding of risk management concepts and terms in the context of medical device development. It applies to all stages of the life cycle of a medical device, including design, manufacturing, distribution, use, and disposal.

Benefits of Implementing ISO 14791:2018

Implementing ISO 14791:2018 can bring numerous benefits to both manufacturers and end-users of medical devices. Firstly, it ensures that potential risks associated with the use of the device are identified and controlled throughout its entire life cycle. This reduces the likelihood of adverse events and enhances patient safety.

Secondly, following the standard's guidelines enables manufacturers to demonstrate compliance with regulatory requirements related to risk management. It facilitates market access for their products and enhances their reputation in the industry.

Key Elements of ISO 14791:2018

ISO 14791:2018 emphasizes a systematic approach to risk management. It provides a framework consisting of several key elements:

Risk Management Plan: A document that outlines the risk management process for a specific medical device.

Risk Analysis: The identification of hazards associated with the device and the assessment of their potential impacts.

Risk Evaluation: The determination of the acceptability of risks based on criteria such as severity, probability, and detectability.

Risk Control: The implementation of measures to reduce or eliminate identified risks.

Residual Risk Evaluation: The assessment of risks that remain after risk control measures have been implemented.

Production and Post-Production Information: The collection and analysis of data related to the device's performance and any reported adverse events.

By following these elements, manufacturers can effectively manage risks associated with their medical devices and ensure their safety and effectiveness in real-world use.