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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ISO 14971:2019 – Changes in the Current Version of ISO 14971

The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO 14971:2007. Overall, no tectonic shifts have occurred – the risk management process itself remains largely unchanged. Nonetheless, there are important clarifications and updates in ISO 14971:2019 that you should be aware of. Get up to speed on the changes with our ISO 14971:2019 Risk Management Class. In reviewing the new ISO 14971 standard, pay particular attention to the highlighted sections below. ISO/TR 24971:2020 Is […]

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Yes, You’ve Evaluated Every Risk – But Are You Properly Documenting Medical Device Benefits?

Risk. Risk. Risk. Some days it can feel as though our sole mission as medical device regulatory professionals is to raise red flags about what could go wrong. Without a doubt, safety is where the focus should be. Yet, when ISO 14971 instructs us to reduce risks “as far as possible,” it is easy to lose sight that there is a benefit-risk tradeoff. So while the focus of your job may be on reducing risk, the reason we create medical […]

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