It would be most challenging to work under a matrix organization. This is simply because the resources on your team are split. Situations like that can lead to staff getting burnt out due to the amoun...

In my opinion, with a new group of people, it is better to have the project group with people who are competent in their expertise vs people who you have a good relationship with. It would be great if...

"As far as possible" to me would be to the point of common sense. Meaning, depending on the target product audience, there should be a level of intelligence that you expect the user to have. Take a to...

Labels are an essential part of risk management, but I agree that they are the least useful. This is because (from my experience) people do not normally read the warning labels. Think about things tha...

Personally, for any business/professional meeting I think it would be most effective to follow Robert's Rules of Order. (At the end of the post I will link a basic overview of what that is) The first...

As jz365 has mentioned, the EU has a different regulatory body than the US. For the EU, no design controls are not "needed". Yet, that will limit your market size because it is needed in the US. I wou...

Each of the documents explains the other's disadvantage. Not being specific enough can have it's drawbacks, as well as being too specific. The advantage of the DID is that you can show a customer a br...

Verification is making sure what you say is going to happen actually happens .. If you say a product is supposed to do something and it does not do it, you'll end up getting sued and, even worse, coul...

For biological statistics, t & z tests are useful for data analysis. You would want your power to be at lest 80% to be considered a good test, however the higher the power the better. you would us...

I personally would not skip the validation process. 1) you would want to confidently state what parameters your device will conform to without any doubt. 2) If anything happens, it leaves you open to ...

Honestly, minutes are one of the most important aspects of a meeting. If something is not in the minutes, it did not happen. That's why it is important that the person taking the minutes is paying att...

Clinical trials are necessary because regardless of the amount of pre-clinical trials you conduct, nothing done pre-clinically will directly transfer over to a clinical observation. In other words, us...

I do not think having a clinical background is overly necessary to perform clinical research. Like any job, you end up getting trained to do things the specific way your employer wants you to do them ...

I would go with a Double Blind study whenever possible. Utilizing a single blind study can lead to researcher's bias. Researcher's Bias is when the researcher looks for data that confirms a specific o...

Firstly, the video is hilarious! Secondly, the video is a purposely over-the-top version of the comic strip. A lot of the time people may not realize how their requests can be on different spectrums. ...