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Risk Management Plans Guide

Example Risk Management Plan Medical Device

It is almost always part of the technical documentation of the medical device. The risk management plan is actually a document that defines these activities, responsibilities and risk acceptance criteria for your risk management process. It is important to record the lifespan of the medical device along with the risk management measures to be implemented.

It is truly a document that needs to be updated throughout the device lifecycle and it interacts with several other processes of the quality management system within the organization such as clinical evaluation, post-market surveillance, vigilance reporting, not to mention development and design. In addition, it is important to recognize the responsibilities for your review and approval of risk management decisions. Responsibilities for your implementation of specific risk management activities will be defined in the risk management plan.

The risk management plan contains specific methodologies for your overview of risk management activities. In the case of medical devices containing software, specific competencies in both software development and risk management are essential. Risk acceptability criteria are central to the risk management plan.

Additional information about the assessment process is highlighted within the chart below. It is perfectly up to the business to device whether exactly the same risk acceptance policy should be relevant for a particular medical device or even the same criteria can be used on all medical devices. The medical device manufacturer determines the risk acceptability criteria under the specific risk acceptability insurance policy.

In such cases, the criteria for accepting danger should depend on the severity of the damage. For software-based medical devices, a different risk acceptability criterion will be asked, as the probability of the damage should not be estimated. Both of these verification activities can be performed in a different way, for example by design review, design specifications or development and design verification in quality system.

In these situations where the probability cannot be estimated, the residual risk acceptance criteria should consider the risk control measures that have been taken and the strength of those risk control measures to reduce the likelihood of damage. The amount of data can be significantly large, so the company will have a sold out process to perform the analysis of the information and also actively identify trends. It is fundamental to develop a reliable process before your variety of production and post production information can be used to feed the hazard management process.

In conclusion, the hazard management plan is one of the essential documents for your risk management plan. Statistical techniques should be considered to assist in the processing of the collected data. In this article, we have discussed in detail what should be addressed in the hazard management plan, as well as the interactions of the strategy, along with other quality system methods such as clinical validation and post-market surveillance.

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