{"id":5195,"date":"2022-08-20T06:17:10","date_gmt":"2022-08-20T06:17:10","guid":{"rendered":"https:\/\/stendard.com\/?p=5195"},"modified":"2023-09-27T03:21:56","modified_gmt":"2023-09-27T03:21:56","slug":"iso-14971","status":"publish","type":"post","link":"https:\/\/stendard.com\/en-id\/blog\/iso-14971\/","title":{"rendered":"ISO 14971 Explained."},"content":{"rendered":"\n
Before diving into ISO 14971 Medical device – Application of risk management to medical devices, we must first understand risk management. Unlike business risk management, ISO 14971 risk management is a process of identifying, analysing, controlling, and preventing failures that can have dangerous consequences in the usage of medical devices.<\/p>\n\n\n\n
Organisations must conduct risk management for medical devices as associated risks related to a failure in medical devices can result in dire consequences not only to the patients who went for a medical procedure but also to the organisations themselves.<\/p>\n\n\n\n
Suppose your medical device companies plan to sell medical devices in the United States or Europe. In that case, your organisations need to have a risk management system implemented as part of the regulatory requirements by Quality System Regulation (QSR) and Medical Device Regulation (MDR), respectively. ISO 14971 risk management is an international standard adopted by regulatory agencies that the medical devices company establishes in their risk management activities throughout the product life cycle.<\/p>\n\n\n\n
ISO 14791 document specifies terminology and principles and provides a risk management framework for medical devices, including in vitro diagnostic medical devices, which help organisations identify hazards, perform risk estimation, examine risk analysis and exert control measures to reduce risk.<\/p>\n\n\n\n
The intended usage of the risk management process from ISO 14791 is catered to the entire product lifecycle from the initial conception to final decommissioning and disposal. Your organisation may apply ISO 14971 while implementing your organisation’s quality management systems, such as ISO 13485.<\/p>\n\n\n\n
According to ISO 14971, the standard does not apply to:<\/p>\n\n\n\n
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ISO 14971 document requires manufacturers to establish objective criteria for risk acceptability; however, acceptable risk levels are not specified. This risk management system’s requirements are integral to ISO 13485 – Quality Management Systems.<\/p>\n\n\n\n
ISO 14971 risk management for medical devices is a comprehensive process whereby your risk management team must consider every part of the medical devices life cycle for risk evaluation, not necessarily medical devices. This includes external and internal processes such as suppliers, procurement, sales, business development, quality system procedures and consumers should be an integral part of the risk management for the medical device industry.<\/p>\n\n\n\n