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 that works for a person then who is at risk now?

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 is very similar to the medical device. Those steps are:
1) Risk assessment
2) Risk control
3) Risk…[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 to inform patience the proper way to take the painkiller or product, so that way it could reduce the risk. Think about it for a…[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 going to execute my DDP it will make it a lot easier for me. Everyone is making some valid points! If there were four other major components that could be…[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 a good use to the human body. Just think about if there is no evaluation is not completed the device can be harmful for patients.…[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 require the students in that course to have to do a test plan document. It often seems as though we think a product has to be…[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 me these are a few questions that I believe should be asked , because it makes an impact on the design concept and will help it…[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 growth and changes within the design process each step meaning the changes that may occur for at any instant; for example what if the raw material may need…[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 have a different name for it. According to the FDA design control is a major factor for medical devices manufacturers. I…[Read more]