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 ca...

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 h...

"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 intell...

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 normal...

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...

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...

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 advanta...

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...

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, how...

I personally would not skip the validation process. 1) you would want to confidently state what parameters your device will conform to without any dou...

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 importan...

Clinical trials are necessary because regardless of the amount of pre-clinical trials you conduct, nothing done pre-clinically will directly transfer ...

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 th...

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 re...

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...