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Risk management fundamentals

Overview of risk analysis techniques for system safety
FMEA continues to be the dominant risk analysis technique used in the medical device industry. It is time to expand our toolkit.
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Naveen Agarwal, Ph.D.
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Mastering risk analysis for excellence in system safety
Introducing a new series on Let's Talk Risk! to help you build a solid knowledge of medical device system safety and commonly used risk analysis…
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Naveen Agarwal, Ph.D.
Bonus feature: Free video lesson on the risk management process for medical devices
A special bonus feature for subscribers of Let's Talk Risk! newsletter. This is a video lesson from the on-demand ISO 14971 certification training…
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Naveen Agarwal, Ph.D.
12:39
ISO 14971 Fundamentals: A primer on P1, P2 and how they relate to probability of harm
There is a lot of confusion in the device industry about basic probability concepts, which often leads to incorrect application in practice. Here is a…
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Naveen Agarwal, Ph.D.
An ideal medical device
Imagining an ideal medical device as a benchmark for evaluating benefit-risk in a more structured and quantitative framework.
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Naveen Agarwal, Ph.D.
Delay in treatment can be deadly; analyze it carefully
There are many recalls and FDA warning letters related to delay in treatment caused by medical device malfunctions. Here are a few considerations to…
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Naveen Agarwal, Ph.D.
ISO 14971 Fundamentals: Risk management plan
A detailed look at the 7 essential elements of a risk management plan and how they link to the requirements in ISO 14971.
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Naveen Agarwal, Ph.D.
ISO 14971 Fundamentals - Using standardized terms for more accurate risk analysis
Using standardized codes and terms for potential harms helps you in more accurately estimating and evaluating risks, and in responding more quickly to…
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Naveen Agarwal, Ph.D.
2
ISO 14971 Fundamentals: Characteristics related to safety
Best practices for identifying safety characteristics and connecting them to design controls.
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Naveen Agarwal, Ph.D.
5
ISO 14971 Fundamentals: Reasonably Foreseeable Misuse
Reasonably foreseeable misuse in the context of ISO 14971 is more than use-error.
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Naveen Agarwal, Ph.D.
ISO 14971 fundamentals - policy for establishing criteria for risk acceptability
ISO 14971 requires top management to define and document a policy for establishing criteria for risk acceptability. Here are 5 elements and best…
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Naveen Agarwal, Ph.D.
ISO 14971 fundamentals: understanding sequence of events
It helps to keep the big picture in mind when identifying foreseeable sequence or combination of events.
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Naveen Agarwal, Ph.D.
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