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Risk management fundamentals
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…
May 8
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Naveen Agarwal, Ph.D.
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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.
Mar 20
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Naveen Agarwal, Ph.D.
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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…
Feb 7
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Naveen Agarwal, Ph.D.
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ISO 14971 Fundamentals: Characteristics related to safety
Best practices for identifying safety characteristics and connecting them to design controls.
Dec 20, 2023
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Naveen Agarwal, Ph.D.
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ISO 14971 Fundamentals: Reasonably Foreseeable Misuse
Reasonably foreseeable misuse in the context of ISO 14971 is more than use-error.
Nov 15, 2023
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Naveen Agarwal, Ph.D.
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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…
Oct 18, 2023
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Naveen Agarwal, Ph.D.
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ISO 14971 fundamentals: understanding sequence of events
It helps to keep the big picture in mind when identifying foreseeable sequence or combination of events.
Sep 27, 2023
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Naveen Agarwal, Ph.D.
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ISO 14971 fundamentals: risk management file
Traceability and completeness of risk management need to be clearly demonstrated
Aug 16, 2023
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Naveen Agarwal, Ph.D.
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