Accepting risk, to a certain extent, should be the case especially when the need is urgent and there are too many factors to consider as individual ri...

In reality, there are no 0-risk devices or products on the market in terms of the medical industry. Even devices that may have 100% success rates tech...

At some point, there is a tradeoff between mitigating risk and actually increasing the risk through "mitigation techniques or processes." Of course, b...

In general, there is a clear line between neglect and making mistakes. At times, people might change or alter a process and forget to note it down. Al...

At times, things like regulations may seem like barriers. But in reality, they aid in making a more robust device and reduce the chances of adverse ef...

Since they are two distinct aspects of the product development process, it is important that both are still completed. Although they do overlap, somet...

One issue that would arise is the failure of meeting its intended purpose. Without proper design controls, a product would most likely never make it t...

From what I have seen, most feedback can be influential and positive in terms of making a device or product better. Feedback can be in any form, and f...

I think this is a great question to consider since it is something that most of us, as engineers will eventually face. What is more important, user ne...

In my opinion, a single-blind study could work in a majority of the cases since the researchers/investigators do not really have significant effect on...

I completely agree that GCP guidelines are done correctly in terms of safety and efficiency. GCP is extremely important in ensuring the validity of a ...

I would prefer to be a monitor (clinical research associate) of clinical research because it seems very interesting to do their job. A monitor basical...

I absolutely believe that the marketing/advertising is targeted towards specific demographics, especially on platforms or TV programs. TV is one of th...

Personally, I do not see a huge correlation between the colors of devices in terms of medical devices and their branding. Although, you can say that c...

If I were to change career paths but stay in the same industry, I would definitely go into medical sales. Although marketing is appealing, it is not a...