The ACHIEVE Blog

Medical devices are expected to operate safely and effectively throughout their entire lifecycle, not just at the point of regulatory review before marketing authorization. However, it proves to be qu...

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

This case study...

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.

ISO 14971, the I...

Note: This is an excerpt of a podcast originally published on the Let's Talk Risk! newsletter. Listen to the full podcast here.

The practice of risk management in a heavily regulated industry such ...

Reasonably foreseeable misuse in the context of ISO 14971 is more than use-error.

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

Note: this article presents an excerpt of a webinar presented to subscribers of the Let's Talk Risk! knowledge-letter. Watch the full webinar here and subscribe.

Good planning is essential to the s...

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 likel...

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 the probab...

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 decisions...

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 acce...

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 management f...

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 hazardous ...