The ACHIEVE Blog

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...

ISO 14971 requires the top management to evaluate the suitability and continuing effectiveness of the risk management process for their medical device. But this evaluation is generally done rather...

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,...

In this episode, we focus on some of the practical challenges in implementing a severity scale to analyze the risk of harm associated with medical devices. Industry practice is to use a 1-5 scale...

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...

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...

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...

Global regulatory authorities require the use of standardized codes for reporting adverse events. Here are two reasons why you should also use standardized codes and terms in your risk...

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...

You are developing a new implantable medical device to facilitate a less-invasive surgical procedure compared to your current legacy medical device. How do you analyze and document both...

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...