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TraceyMraw
@traceymraw
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Joined: Sep 8, 2019
Last seen: May 2, 2021
Topics: 1 / Replies: 80
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RE: Discussion Topic: Your organizational type

I would like to work in a matrix organization because of the ease of transferring information between projects and departments. Though there may be sc...

5 years ago
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Replies: 31
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RE: Discussion Topic: Risk Management, Risk Analysis

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

5 years ago
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RE: Dealing with risk

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 an...

5 years ago
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RE: Verification Protocol

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 necess...

5 years ago
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RE: Design Documents in Academia

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 bei...

5 years ago
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RE: examples of controlled device changes

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 ...

5 years ago
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RE: Minutes for meetings

From my experience, meeting minutes are extremely beneficial for resolving conflicts over matters that were discussed in the meeting. Any time an issu...

5 years ago
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RE: Design Verification & Validation

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...

5 years ago
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RE: Design Control Experience

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 thi...

5 years ago
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RE: Clinical Trial Roles

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 par...

5 years ago
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RE: Discussion Topic: Having a "clinical background"

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 ...

5 years ago
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RE: Clinical Trial Experiment

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

5 years ago
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RE: Discussion Topic: The Fifth "P" of Marketing

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 ...

5 years ago
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RE: Marketing Strategy

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...

5 years ago
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