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 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 ...

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...

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...

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 help you buil...

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 pro...

This week, we kicked off our Weekly Live Discussion Series! We talked about Hazard Analysis and why it becomes challenging if you try to combine it within a FMEA (Failure Mode Effects Analysis). Check...

If you are using an FMEA to define sequence of events and hazardous situations relevant for your medical device, you are likely having a difficult time. Here is an easier, more direct way to meet ISO ...

According to the latest news, a final draft of the ZA and ZB annexes for harmonization of ISO 14971:2019 is currently going through the voting process

ISO 14971, the International Standard for Risk M...

Evaluating benefit-risk of a medical device is no easy task because it involves making a decision about their safety and effectiveness with very limited information. 

There is no doubt that medical d...