I think the best way to ensure Document Control requirements are fulfilled is to train the engineers to those high standards as soon as they start wor...

I work for a company that was audited for several months and it was a very stressful time for not only Quality and Regulatory, but for basically every...

I currently work for a mid-size medical device company and while I do not think there is technically bad blood between Quality and the other departmen...

As stated before there are many reasons for a recall to occur. From personal experience I do not think it is the FDAs fault most of the time. The only...

Device: Antibiotic-Releasing Hip Stem Type: Combination of a device (hip stem component) and a drug (antibiotic component) but the primary mode of act...

I do agree that the FDA is strict to an almost oppressive extent, but given the types of products they are dealing with, it makes sense. The rigorous ...

As mentioned in Dr.Simon's lecture on managing a research project, there are several key steps to follow if you are going to complete it successfully....

Obviously, a lot of people are saying they would prefer to conduct research which they will see implemented in their lifetime, if not within a decade ...

I work in Industry currently so I'll talk a little about the pros and cons of research on that side of the spectrum. There are definitely some pros su...

As mentioned in Dr.Simon's lecture on managing a research project, there are several key steps to follow if you are going to complete it successfully....

I have seen many case studies on Engineering Ethics in which managers have not heeded the device of their underlying engineers, such as the Challenger...

The Work Breakdown Structure (WBS) is probably the first thing you should do when working on the Planning Phase. This is a very broad outline but it s...

I do not think that missing milestones is necessarily a failure. To me, milestones are sort of like soft checkpoints in a project. You should do every...

It all depends what you define as "Engineering Student" because that could mean Undergraduate or Graduate studies. In terms of the early years studyin...

This is something I have also struggled with, as someone who is currently in the Industry and also working towards a Master's Degree (MS) in Biomedica...