Excellent question; I think it’s very restricted, but the whole process is wrong. Why do the physicians have to take his wife to the business meeting anyway? I agree with the second comment, there is no reason for a spouse…   Read more»

Everyone is making valid points; I do not have any similar experience but I do think the scenario that you gave is very interesting. My input on this is that the company put themselves in a tough situation for hiring…   Read more»

I would like to work in a functional organization because it will be easier to work on the project with the people in your department. Even though it may have a disadvantage, I rather have one person make the final…   Read more»

The article you posted was very interesting. Currently at my job the organizational behavior is all over the place and it impacts the way we all operate. Learning about OBM made me realize that some companies lack that aspect and…   Read more»

That is a tough question, but forming a great team is putting individuals together that are good at their roles, communication and other skills. I don’t think it’s sometimes good to put the people you have a good relationship with…   Read more»

But if the patient can not understand the residual risk that means FDA is allowing products to go on the market with risks not described clearly in the labels. What if the risk is high, but thats the only medication…   Read more»

I have no experience with risk analysis, but i think there is no major difference between the medical device and pharma world. After doing a little research I found a website/pdf that broke down the quality risk management process which…   Read more»

I do not think it is fair for companies do that to patients because they put them into so many health risk that are not safe especially if we look beyond painkillers. I think they should create seminars or tutorials…   Read more»

That is a tough choice because all of those are very important to DDP! If I had to choose one it would be scope management plan; the reason behind that is that having a general scope of how I am…   Read more»

I do believe that even if there are no changes after the verification the human factors evaluation is needed because it allows you to check the quality of the product. Also, the evaluation can show if the product can be…   Read more»

I didn’t do my undergraduate at NJIT ,but I believe it’s common for a medical device to go through common steps. Those steps may just have a different name and ask for specific information. I think it’s good that they…   Read more»

Design inputs are very broad because every indivdual that may be on the team has different ideas. An example could be : -how much life span will this product have? -who are our customers? -what are the safety factors? To…   Read more»

At first before reading the other comments I thought that design control was needed in the EU, but I saw that it is not mandated unlike the US. The pros in a DHF are that allows you to see the…   Read more»

Design controls are a set of methods used to complete/finish your design and it goes into more details are you all have already mention. The crazy thing is that all types of industries use design control in some sort,but may…   Read more»