The fact of the matter is that whether its done by the books or not, bribery can be done very easily. Paying for a spouse’s dinner? That’s the least that a company can bribe someone if they wanted to. Besides,…   Read more»

I disagree with most of what people are saying. Oral contracts are not difficult to prove as long as there is just one witness. Oral contracts are just as binding as written contracts. Although there is no disputing a written…   Read more»

This class has helped me realize that my initial desire to work in RD is still what I want to do with my career. This course does not go into any actual research of new devices, and why would it….   Read more»

I think that the functional org structure is the most effective structure. This way, you can hire experts in their respect fields who don’t need to know too much about other parts of the company. Granted, it’s important to understand…   Read more»

I think it depends at what stage of the company you are in. For example, an RD team doesn’t necessarily need to have that great of a relationship or have an immense amount of trust between them. Their job is…   Read more»

I think if I were to start up a company, I would try to go with a structure similar to the divisional market based org structure. As stated in the article, this is structured for a specific niche of market,…   Read more»

I think what it comes down to is essentially the honor system. It may sound quite counterproductive because, of course if you give companies an inch, they’ll take a mile. However, if something during the production of an medical device…   Read more»

As I understand it, dealing with risk is split up into three different categories: Risk Analysis: Risk analysis is simply a definition of risk. Basically, if we do x, y and z may occur. Risk Assessment: If y and z…   Read more»

Yes I was going to mention the SWOT analysis. Preliminary risk assessments are hard to quantify sometimes, so there are many times when the best way to assess each risk is to go back and evaluate what the company has…   Read more»

One really important test is a fatigue tests and heat test. A the fatigue test is essentially a device that will put a certain amount of cyclic loading to the device and will determine how many of those cycles it…   Read more»

When I was the president of a club during my NJIT undergrad tenure, the secretary of the club introduced the concept of minutes during our weekly e-board meetings. I didn’t really understand the concept of minutes other than just notes…   Read more»

The verification refers to the process that deals with evaluating the customer needs and “verifying” that what the scope is focused in on is based on the customer needs. Validation refers to the process of complying with regulations and specifications…   Read more»

Thanks for this post. I think the scope management is the most important, not to say the others are unimportant, but understanding what needs to be done in the amount of time given is the best way to complete an…   Read more»

Personally, I think that this topic should be considered with the famous motto “If it ain’t broke, don’t fix it” . Obviously, these documents and the protocol to make all these devices safe and effective are necessary. However, if these…   Read more»