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 working. I know when i first started working I had to...

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 department. It is a complete effort to comply wit...

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 departments, tensions sometimes escalate. I am in the manuf...

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 reason it would be is a lack of auditing a certai...

Device: Antibiotic-Releasing Hip Stem Type: Combination of a device (hip stem component) and a drug (antibiotic component) but the primary mode of action is as the hip implant. This product will then ...

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 and lengthy process of releasing a new product to ...

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. The Initiating Phase would consist of a lot of th...

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 or so. This is known as instant gratification and ...

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 such as working on more feasible and short-term proj...

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. The Initiating Phase would consist of a lot of th...

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 disaster. I think in order for a manager to reall...

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 still lays the framework for the entire project. It...

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 everything in your power to make sure that the certain ...

It all depends what you define as "Engineering Student" because that could mean Undergraduate or Graduate studies. In terms of the early years studying as an undergrad, I would probably advise to purs...

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 Biomedical Engineering. Specifically, I am working as a Co-...