If you already know the basics, skip to the second post on risk management planning. Download it here. From a distance, risk management seems straightforward. Seems easy, right? Ah, if only life were so straightforward.
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It is critical that all medical device manufacturers, including developers of software as a medical device and in vitro diagnostic devices, understand the changes to the new standard and how to comply with them.
One major organizational difference is that the Technical Report TR is now a necessary supplement to the standard. Guidance on hazard identification, risk concepts and techniques, risk management for in-vitro diagnostic devices, and risk management plans have all been relocated out of the standard and into TR The medical device community will also be introduced to revamped definitions of terms within ISO Readily predictable human behavior is basically expecting how someone might misuse the device in normal circumstances, intentionally or not.
An analysis of this type of misuse must be conducted as part of risk management for a device. There is also a new emphasis on examining the benefit-risk balance for a device as pertains to monitoring post-production activities. The intent of this is to continually analyze a device post-production in order to update the risk management process.
For example, if clinical data reveals that the device risks outweigh any benefits to the patient, this will call for a re-analysis of the risk management file for the device. ISO aims to clarify the activities related to risk management for medical devices. While no major changes have been made to the overall process of how to conduct risk-management, medical device manufacturers will need to spend some time examining the details associated with each change in the new standard to ensure they are aligned completely with each requirement.
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MDD Europe: Use EN ISO 14971:2012 or ISO 14971:2007
For example and more specifically, take a look at ER 1 in Annex I. Therefore, the process of harmonization of standards was followed, resulting in 7 content deviations. My first reaction at the time was the same: B However, if you really read the argumentations and think a little bit further, in light of REAL risk management most of them do make sense.
Risikomanagement – DIN EN ISO 14971 (de)
Application of risk management to medical devices British Standard 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 process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are 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. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system.