ISO 14971 for Medical Devices – Application of Risk Management to Medical Devices
The factors involved in mitigating risks in the medical device industry are large and complex. Risks can be related to injury, not only to the patient, but also to the user and other persons. Risks can also be related to damage to property (for example objects, data, other equipment) or the environment. In ISO 13485, there are references to ISO 14971 as a tool for assessing medical device risks.
This document specifies terminology, principles, and a process for risk management of medical devices, including software as a medical device and in-vitro diagnostic medical devices. The intent of ISO 14971 is to assist manufacturers of medical devices to identify potential medical device hazards, evaluation of the associated risks, controls for managing these risks, along with monitoring the effectiveness of the controls. This standard is applicable to all phases of the life cycle of a medical device.
The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
ISO 14971 does not apply to decisions on how a medical device is used in a clinical procedure. It also does not apply to business risk management, which should be addressed by ISO 31000. This document deals with processes for managing risks associated with medical devices. Guidance on the application of ISO 14971 can be found in ISO/TR 24971. It is important to understand that all information in ISO TR 24971:2020 is strictly for guidance, and is NOT A LIST OF REQUIREMENTS.
Additionally Annexes A, B, C in ISO 14971:2019 is for guidance only, and not a part of overall requirements. This is often overlooked by many users, and Annex A is the rationale for the requirements in the standard. Annex A should be read by anyone using the standard to Improve understanding of the reason for the requirements
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