Risk Management Review, Reporting and Postmarket Planning

As part of the risk review process, you’ll need to assess your risk management activities against the risk management plan on three levels: 1 – Has the plan been implemented appropriately? 2 – Is the overall residual risk acceptable? 3 – Are production and post-production information collection methods implemented? The summation of answers to these questions becomes your risk management report, which is part of your larger risk management file. The report documents the conduct and results of your risk […]

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Medical Device Risk Control and Risk Management Tools

A big portion of risk management is evaluating and reducing risk. However, sometimes the likelihood of harm resulting from a hazard is quite low and mitigating that hazard may not provide any tangible reduction in risk – in fact, it may diminish your device’s benefits. Here’s a quick example. Let’s say you produce a blood glucose meter. To improve visibility, you consider making the display color. However, doing so would introduce a new hazard: color screens require more power, and […]

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Creating a Medical Device Risk Management Plan and Conducting a Risk Analysis

Your risk management plan outlines the process of how you will conduct risk management for a particular device, and it becomes part of your risk management file. Importantly, the process should be repeated throughout the life cycle of the device. The overall risk management process usually is documented in a general procedure containing common risk management activities for all devices. Then one or more individual risk management plans “personalize” the content of the procedure to provide more exact details for […]

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Basics of Medical Device Risk Management and ISO 14971:2019

From a distance, risk management seems straightforward. You have a device, evaluate its potential risks, mitigate those risks, monitor them over time, and you’re done. Seems easy, right? Ah, if only life were so straightforward. The reality is that risk management is one of the more complex aspects of regulatory compliance, simply because risk comes in so many flavors and perceptions of severity. Plus, the probability of harm actually occurring can be estimated quite differently.   This is a four-part […]

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