Having a detailed and accurate Quality System is extremely important for a medical device company. The Quality Systems ensure that essentially everything within a medical device company is documented...

I agree with this. As an engineer that is outside the quality department, looking for continuous ways to improve processes is key for a company to continually increase efficiency and productivity. A...

With more and more companies wanting to adapt a lean culture to reduce downtime, increase efficiency, and reduce waste improving Quality and Manufacturing practices is key. I believe one of the first...

I believe it comes off as a burden because Quality are the people who tend to reject or question every detail of a report or analysis. You want to get product that moves out the door in a timely matte...

Going on a tangent as well - I understand the idea of simplicity that technology adds. But to turn an app into a medical device that is used by doctors to make decisions seems foolish. I'm for the i...

Two years ago I was working on BSI from a Supply Chain perspective. It was interesting in the fact that we had to understand different countries regulations in the European Union. Some required regul...

The Tylenol Recall in 1982 was what started the idea of recalling products off shelves. Johnson and Johnson had to deal with this issue and James Burke, the CEO at the time, was commended for the way...

After the brain is frozen and transported, I assume to a customer, would the customer try to use the brain, realize it doesn't work, and then go back to you? I assume after that you do an investigati...

I would like to know the answer to this as well.

Interesting. Did they go back and re-do the protocol and initiate the the trails again after realizing the diminished interleukin levels? If they conducted it again, what happened afterwards?

I've never had the opportunity to conduct or be a part of a team doing pre-clinical / clinical research. For those of you who have done it in the past or are currently working in this type of researc...

The main motivating factor, in terms of animal studies, is conducting the study on these animals and seeing what the results are. The results will demonstrate if the research for the university is wo...

Generally speaking, research in industry is investigate and completed "faster" usually because they have the resources in terms of money and experienced people. It also depends what type of research t...

It depends. If you are missing milestones that need to be accomplished that are highly critical to compliance and basically keeping the customer/patient safe, then I would be able to accept missing it...

Most of the projects that I have worked on, which have had a big scope and long timelines, has followed a format in which one person is the Project Manager and underneath the project manager are a bun...