The ACHIEVE Blog

Note: this article is a summary of the original article published on the Let's Talk Risk! newsletter on Substack, a reader-supported publication.Read the full article here.

Summary

Note: this article is a summary of the original article published on my Let's Talk Risk! newsletter. Read the full article here.

Summary

This case study provides an easy way to estimate...

People perceive risks differently. Each one of us has our own perception of risk, which affects our judgments and decisions.

Research shows that risk perception influences our judgments and...

ISO 14971 requires identification and documentation of hazards and hazardous situations as part of risk analysis. If you are using an FMEA as the only way to document applicable hazards and...

A clear understanding of reasonably foreseeable sequence or combinations of events leading to hazardous situations is critical for identifying risks associated with the use of a medical device. In...

At first glance, the term hazard appears quite intuitive to understand. According to the dictionary, it is the source of danger. But it is not so easy to precisely define it when doing risk...

Although not a mandatory requirement of ISO 14971, it is a common practice in the medical device industry to use the P1, P2 approach for estimating the probability of harm (POH). In many cases,...

Estimating risk of harm for your medical device is a requirement of ISO 14971:2019. However several practical challenges make it difficult to accurately estimate the risk of harm. This is partly...

Should we treat it as a hazard, a hazardous situation or a harm?

A diagnostic device gives a false or invalid result causing a delay in diagnosis and therapy. The software controlling a medical...

When making decisions about investigating customer complaints using severity of harm, make sure the severity levels are correctly and consistently applied.

In a recent warning letter, the FDA cited...