An NDA and a patent both help protect ideas, but they are not substitutes for each other. An NDA is a private agreement that keeps information confide...

If you’re asked to sign an NDA, the main thing to remember is that you should never sign something you don’t fully understand. An NDA is still a legal...

A verbal/oral agreement is essentially the same thing, both mean an agreement made through spoken communication. Verbal agreements can be legally bind...

If I had to choose, I’d prefer working in a matrix-based organization as well. It offers the best mix of both worlds: the deep expertise of functional...

Successful Scenario (Strong Matrix)A medical device company launches a new imaging probe. The project manager controls all budget and timeline aspects...

Medical device companies need to change their internal operations because healthcare organizations now use value-based care models which require them ...

I definitely believe risk management is an important part of the planning phase. It’s not a waste of money or time. In fact, it often saves both in th...

It’s important to look at hazards and hazardous situations separately because they happen at different stages of risk. A hazard is something that can ...

A real example of this happened during the 2014 Ebola outbreak, when healthcare workers in West Africa faced serious exposure risks. The hazard was th...

I think risk acceptance means recognizing a risk but choosing not to take any immediate action because the potential impact is minor or the cost of co...

Yes, I definitely feel safer knowing that validation and verification are key parts of the medical device development process. The process verifies th...

Risk management operates together with design verification and validation to detect all possible hazards which get evaluated and managed from start to...

Medical device development needs design control as its fundamental requirement to confirm that products meet safety standards and quality benchmarks a...

The placebo effect creates difficulties in clinical trial result analysis because it demonstrates how mental factors can affect actual physical health...

Researchers use various approaches to minimize placebo effects while confirming that their results show the genuine effects of treatments. The most co...