Validation is the process that guarantees the product quality that the end user expects. The design must provide that expectation with a process that...

Medical devices must be safe and reliable. With data from the FDA that states that "44% of voluntary recalls from October 1983 through September 1989...

As with many things in medicine and healthcare it looks good on paper. In action is where the ethical dilemmas present themselves. On one side there...

Experience is always valuable. That is even more important in clinical research. There is huge liabilities that are present when conducting research...

I live in a country where many people believe that we should have the right to choose. Choose to own a gun, choose to say what we want, choose to vot...

I taught an entrepreneurship class for a summer camp we did for our students. In that class we watched a video on how Coca Cola was started. At the ...

@jafar The fact that the fate of the business is not connected to any individual owner upon there death is extremely important. The flexibility with ...

At this time I would start an LLC. I would start an LLC because it is cheaper and easier to start. An LLC will still provide the legal protection th...

I have not worked in a regulatory project but I have worked in government inspections and enforcement. My first experience in the field was in zoning...

QA/QC in relation to ethics can present interesting dynamics. I can go back to my college job as a cashier at Home Depot. We were asked to meet perf...

If I was to simplify the difference between quality control and quality assurance, I would say that QA puts systems in place that supports the creatio...

@llefevre This is a very interesting topic. Companies can't be innovators and pioneers if they have not mastered the other needs outlined in the pyra...

I have not personally signed a non-compete agreement. It seems as though in biotech that it would almost be a necessity. With the success of biotech...

The type of organization that works best is the one that maximizes management effectiveness. My preference is a matrix organization. The matrix orga...

If I were involved with a medical device development project, biomaterial selection would be important. Choosing the right biomaterial is important f...