In my opinion, one of the biggest improvements that needs to be made to most quality departments, especially at my company, is the communication between quality and manufacturing. A lot of times, quality thinks they have the final say on…   Read more»

At my company I have worked with R&D on many issues which Quality was also involved. As stated by @dbonanno1, R&D and Quality had very different opinions on how to handle most situations, R&D coming from a view of practicality…   Read more»

Like @bb254, I also work for a company that has a document control system that wastes a large amount of time and resources. While I understand the need for a quality management system and the need for quality to review…   Read more»

Human differences can be very beneficial to producing medical devices, but they can also have their drawbacks. When it comes to engineering itself, differences in thoughts, perspective and experiences can be a huge benefit looking at development from different angles….   Read more»

There are many drugs and medical devices that are manufactured and sold in other countries that are currently banned in the US or not allowed to be manufactured in the US. The main reason for this is because the FDA…   Read more»

In academia, research is much more based on the love of knowledge and advancement then it is on how much the research can increase profit or productivity. As Professor Simon suggested in the lecture, most members of academia generally research…   Read more»

While I do think the FDA is very strict, the drugs and devices that they are regulating affect millions of people. That being said, without regulations and strict rules, some of these devices could be harming more individuals then they…   Read more»

@cruzdonato I do not think it is okay to cut corners while doing any type of testing that could provide you with valuable information on how safe or functional a medical device is. Especially devices that are going to remain…   Read more»

@cruzdonato I do not think it is okay to cut corners while doing any type of testing that could provide you with valuable information on how safe or functional a medical device is. Especially devices that are going to remain…   Read more»

I currently work in industry now and I can tell you that I am very happy with my choice. As someone who has always enjoyed starting a project and seeing it all the way through until the final product, it…   Read more»

I have been working under my first project manager for about three years now. My manager almost acts like more of a friend to me than a manager. He is very hands off and trusts me to get a lot…   Read more»

I have not been the manager of any projects, but my boss and I communicate a lot about the projects that he manages. The quick and easy response to this is that it is almost impossible to predict all of…   Read more»

In a medical device company, the best dynamic to have between a manager and an engineer is mutual respect for one another. At my company, my manager and I not only have a mutual respect for each other, but trust…   Read more»

Being a relatively recent graduate and having worked in the medical device field, doing a large amount of process and equipment validation, I have found that a lot of engineers have trouble applying the knowledge they have learned in school…   Read more»

From my experience in the industry, all that you need to enter the industry is a BS degree, a willingness to learn as much as possible, and some good connections. While there are some companies that are looking for someone…   Read more»

In agreeance with a lot of people who have posted here, experience is everything, especially when it comes to FDA regulations and guidelines, design controls, and process validation. When I was a junior in college, I had been working for…   Read more»