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 amount of work given by…   Read more»

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 everyone…   Read more»

“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 tongue depressor for…   Read more»

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 that you use on a daily…   Read more»

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 thing you will need…   Read more»

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 would recommend…   Read more»

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 broad view of what the…   Read more»

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, could hurt…   Read more»

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 use a t…   Read more»

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 a law suit. Whether it’s required…   Read more»

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 attention and takes great…   Read more»

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, using something similar to humans is not the same as using humans….   Read more»

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 anyway. The biggest plus…   Read more»

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 outcome that is beneficial to them. By…   Read more»

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. An interesting point is that “The…   Read more»

For that particular company, I would look at an LLC. Mainly due to the liability they have if something goes wrong. I don’t believe that they have enough revenue to cover a lawsuit and continue to function as a company…   Read more»

I wouldn’t turn down a job offer solely based on the type of company it is. Every job has it’s own experiences which cannot be taken away in case of the company going out of business. For example, say I…   Read more»

As aja38 & vcf3 have stated, a sole proprietorship cannot be passed on. If the father wants to give his business to his heirs then he would have to change the business to an LLP. From there the dad can…   Read more»

To improve upon document control, you have to evaluate what you are currently doing. Is the reason because you are using paper files? You can switch to an electronic database using fancy software which also has the capability to print…   Read more»

There isn’t much that can be done to overcome the bad relation, in my opinion. You could involve the Quality Department as early as you would like in the Project Life, but that wouldn’t change much (if anything). The people…   Read more»