The ACHIEVE Blog

We are stuck in a system focused on compliance. Switch your focus to patient safety instead to get unstuck!

If you ask anyone in the medical device industry why they do risk management, you are...

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...

Medical devices are heavily regulated across the world. In general, manufacturers are required to establish an effective Quality System to comply with regulatory requirements for continued market...

As a medical device manufacturer, you are required to establish and maintain a risk management file for ISO 14971 compliance. But did you know that you can maximize the value of your risk...

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...

If you are looking to get certified in medical device risk management according to ISO 14971, you are probably finding it hard to select the right ISO 14971 certification course that can...

There is a lot of confusion in the medical device industry about the term hazardous situation. It is a common practice in the industry to equate failure modes to hazardous situations, but that is...

ISO 14971 requires manufacturers to establish and maintain a risk management file for their medical devices. A risk management file (RMF) is an essential part of the risk management system, but it...

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...

Analysis of post-market data is critical to ensuring continued safety and effectiveness of our medical devices. It is also a requirement of ISO 14971:2019. A common practice in the medical device...