Risk management is absolutely important for a medical device. These devices will be used on people and/or by people. I would consider it to be unethical if there was no risk management associated with...

“As Far As Possible” allows medical devices that vary in use, class, and risk to be considered safe under the manufactures’ own definition. As an example, the risks for a wheelchair and insulin pump a...

I feel that labels and instructions are used as a last resort to explain the risks to the consumer. If you have ever been on medication on used common medical devices found in a drug store, chances ar...

Like @ridmehta, I also prefer to work backwards from the project deadline. If there are checkpoints along the way with smaller deadlines, I include those also. I have used Microsoft Project in the pas...

I have looked into the regulations in Mexico since they are the second-largest medical device market in Latin America. Like the US, the medical devices are classified into three classes with low risk ...

After learning about design controls in this week’s lecture, looking back at my undergraduate capstone project, I can see these parts were followed even if they were not specifically identified. Each ...

All inputs have outputs, but I believe your confusion may be arising from the document name. There is an input document, an output document, and a design specification document (DSD). From my understa...

In my opinion, input is the most important aspect in design controls. Some examples of design input include: performance, safety, maintenance, sterilization, as well as labeling and packaging. If stan...

My experience dealing with meeting minutes stems from clubs. I would expect these to have similar structures to those taken from medical device development teams. The purpose of minutes is to write a ...

Aside from need, I believe interest could also be inviting. Say that there is a study about concussions, and you happen to play a sport. Because this study pertains to you or someone on your team, you...

I am in favor of this law because it provides hope and a sense of ownership to those with life threatening issues. If a person is allowed to make the choice of stopping treatment or to move forward wi...

As many here have said, a double blind study eliminates the chances of a biased experiment. For this reason, I believe that double blind is better than single blind or unblinded experiments. Let's con...

I would not choose marketing or sales because I much prefer to be actively engaged in the engineering aspect of products. Being completely honest, marketing and sales do not interest me, and they seem...

As I sat here and tried to recall many company logos, there is one color not prominent: purple. After doing a general google search of logos, most consist of red, yellow, and blue. Purple is present i...

@hv42 You are absolutely right, the share a coke campaign was a genius marketing strategy for Coca-Cola. It’s a fun, interactive way to not only make people purchase their product, but also extends...