AMA on Risk Management

AMA #4: How to estimate the probability of software failure and analyze risk?

In the real world, software does not fail in every use. Yet current standards recommend using a probability value of 1. What is the best approach for…

Jun 5, 2024 •

Naveen Agarwal, Ph.D.

AMA #3: Does ISO 14971 require benefit-risk analysis of ALL individual residual risks?

A common practice in the medical industry is to document benefit-risk analysis of all individual residual risk as an added column in risk assessments…

Apr 10, 2024 •

Naveen Agarwal, Ph.D.

AMA #2: Is using "no injury" for severity level 1 inconsistent with ISO 14971?

A common practice in the medical industry to use severity level 1 as a catch-all category to include all product issues that may not directly cause…

Mar 13, 2024 •

Naveen Agarwal, Ph.D.

AMA #1: Security risk assessment and vulnerability monitoring

Launching a new Ask-Me-Anything (AMA) on Risk Management series to answer reader-submitted questions.

Feb 13, 2024 •

Naveen Agarwal, Ph.D.

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