Verbal agreements seem fishy to me because there is no paper trail. If one would have to rely on verbal agreement, it may be good practice to have several witnesses rather than it be between two people. I would prefer…   Read more»

I feel there is no way to gauge about how much information is shared when one signs a NDA. It is based on who is signing the agreement. For example, a company most likely will not tell you their top-secret…   Read more»

When I signed up for this course, I had no idea what to expect. To be completely honest, I did not understand the terms in the course description because I have not had exposure to these topics. In a way,…   Read more»

I would be much better suited as a middle manager because I would trust myself more creating plans to achieve the company vision than to set the vision. It’s not that I am unfit for a leadership role; I’m certain…   Read more»

So far, the project seems to be going well. We have had several meetings which were productive. Up until this point, we are at a comfortable place with the DDP, DID, and Gantt Chart. They certainly can use final touches,…   Read more»

I prefer to have people on my team with a similar work ethic as I do. If I had to create a hierarchy of how to form a project team, this certainly would be number one. The next one would…   Read more»

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 within the planning phase. I read this…   Read more»

“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 are different, however both need to…   Read more»

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 are you have…   Read more»

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 past and I find it’s an easy…   Read more»

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 being Class I. There are two approval…   Read more»

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 of the nine parts were included in a very…   Read more»

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 understanding, the input and output documents are the…   Read more»

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 standards are not specified, the manufacturing team could create an item…   Read more»

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 detailed explanation of every meeting, design alteration,…   Read more»

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 may be interested…   Read more»

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 with a…   Read more»

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 consider the Alzheimer’s example you have provided…   Read more»