In working for a publicly owned company, engineers are not that involved with the opinions of shareholders unless their project holds a lot of weight for the company. For example, if there is a new pr...

If I had ownership of my own company, I would definitely prefer to own it as a sole proprietor rather than anything else. I would do this to have total control over the company and be able to run it t...

When it comes to statistical sampling there are a few factors to consider when writing protocols. One of the main factors is what kind of protocol is being written. Most of my experience is with proce...

The steps of process validation for a process include Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), and sometimes a Process Performance Qualification (PP...

Throughout my time working at a company I have done many different types of validations. Essentially, validations can be done for a large array of tests and products or processes. One type that I have...

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, qual...

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&am...

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...

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...

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 ...

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, ...

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...

@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 ...

@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 ...

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,...