I think the greatest value this class provided by familiarizing ourselves with details of the Medical Device process which will inevitably improve your learning curve when operating at a device compan...

many of my colleagues have expressed to me that they love their job mainly because of the people they work with and because of how exciting their work is. I will also stay at my company because of th...

my biggest motivation is taking care of my family. a few semesters ago I was working on a product design that I had to have the draft finished by the about the end of the semester as the project was ...

I think WMS7's experience working overtime to complete a project on time is likely a main reason people work overtime. while many people are motivated, the motivation is not necessarily to finish the...

something mentioned in the lecture which seems like common sense but likely proves to be extremely tedious is to review all materials before submitting to manufacturing to ensure there are no mistakes...

As a PM, one of my greatest concerns would be time to prototype and manufacturing timeline. Depending on the equipment available and existing projects at a manufacturing company, the production time...

design verification is ensuring that the product that you just spent an extended period of time does what you intended it to do. without design verification there is no way of proving the efficacy of...

Ial4's suggestion to consult with Dr. Malekai is correct for avoiding timeline issues about the animal study, however in this simulation, the initial timeline submitted to management was out of your c...

I think monique expressed how to communicate effectly as personal issues can often affect a persons ability to function. Therefore, speaking to the person and being understanding of their situation c...

I think it is the responsibility of the device producer to ensure that adequate measures are taken to ensure proper validation and quality. while FDA regulations are expansive and precise, they are n...

I agree with the answer posted above that a recall would not be take place with faulty adhesive on labels as it does not have an affect on the safety of the contents inside the bottle. Mislabeling ho...

as some have mentioned previously, I believe the project manager should be a great problem solver. on any team, each member should be capable of completing tasks on their own. it is when there are ...

While some research states that belief may be a contributing factor in the effectiveness of acupuncture, the NIH acknowledges that "Acupuncture may help ease types of pain that are often chronic such ...

I believe project based is ideal for smaller companies because each team can focus without being distracted by details of other projects. however, larger companies or companies with multiple integrat...

In agreement with ashley, it is not the responsibility of the company to retest their device, especially since they are not making any claims about extreme sports. Also, according to the FDA Mission ...