I would like to work in a matrix organization because of the ease of transferring information between projects and departments. Though there may be scheduling conflicts and issues with any individual ...

Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find...

As the previous comments have pointed out, ISO 14971 governs risk management in medical device companies. The major requirements ISO 14971 sets for medical device companies are a safe design of the m...

Similar to the scalpel example in the lecture, I think there are many surgical tools where the risk must be accepted. For tools such as bone drills and saws, taking away the dangerous aspect of the t...

A simple example I can think of is a surgical wrench. This device would definitely require a torque test to ensure that it can apply the torque necessary for the procedures it'll be used in. In additi...

Most of the responses mention documentation in academia being things like lab manuals and lab notes. But if the research being done in academia is being used to develop some type of new medical device...

I believe all changes must be controlled. Whether its a change in some type of documentation or a change in a design input leading to a change in the design of the device. In order to keep an accurate...

From my experience, meeting minutes are extremely beneficial for resolving conflicts over matters that were discussed in the meeting. Any time an issue that was previously discussed is brought up foll...

Most of the posts above explain the difference between verification and validation well. If there is still confusion on it, an example that I've found helpful is say you're designing a new tool for su...

I'm currently working on a project for my undergraduate senior design project in which we are creating the prototype for a new medical device. For this project, my team is working our way through the ...

Out of the clinical research roles, I would be most interested in working as an investigator. My first reason for this interest is I would want to participate in the treatments for the subjects. I als...

I've recently heard from multiple professionals in industry about the benefits of some type of clinical experience. Even if the experience it is less official than a position as a nurse or a doctor, e...

While I was completing undergraduate research at NJIT, I assisted with starting a new study using Functional near-infrared spectroscopy (fNIRS) as an imaging technique. The investigators completed the...

This past summer, the company I worked at utilized local artists to endorse a new product. The target population was young adults and the plan was to start selling the product locally, and as it becom...

One product I've seen advertised significantly, but not at all through television, is the popular app TikTok. This app is a social media platform that allows the user to post videos they create. It is...