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ashleyfitzsimmons
@ashleyfitzsimmons
Eminent Member
Joined: Jan 17, 2018
Topics: 0 / Replies: 32
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RE: Overlapping activities

I think that it is certainly sometimes crucial to go back to the planning phase in order to ensure the success of a project. Regardless of how well a ...

6 years ago
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RE: Dangerous Syndromes for risk management

While it is important to manage risk, it is also important to encourage creativity and risk taking within a company. Risks are what lead to breakthrou...

6 years ago
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RE: Project Scope: When the timeline you have doesn't work

In addition to what ak977 said, the main mission of medical device companies is to improve healthcare. Cutting corners just to increase profit or prev...

6 years ago
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RE: Variance During M&C

I think an important thing to add to this discussion is how to adjust things when out of scope - whether it be due to budget or time. An example is in...

6 years ago
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RE: Challenges to Overcome

I think that an additional topic to add to this discussion is while large corporations experience this issue with class II and class III devices, some...

6 years ago
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RE: Inadequate Testing

Online reviews of this book explain how Lenzer compares and contrasts pharmaceuticals with medical devices. Lenzer makes the claim that pharmaceutical...

6 years ago
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RE: Inadequate Testing

From reviews online, it says Lenzer has written about several devices that have been proven problematic. Investigative journalism can sometimes bring ...

6 years ago
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RE: Interpersonal skills vs technical knowledge

Through getting my bachelors degree at NJIT, I felt that my interpersonal skills have improved tremendously. Different experiences that improved my in...

6 years ago
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RE: Project Manager Skills

Of course emotional intelligence combined with technical knowledge are important qualities in a project manager, as well as all of the qualities peop...

6 years ago
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RE: Validation and Verification

Verification and validation are one of a project’s largest costs. Rework is the only cost larger than verification and validation in a project. If it ...

6 years ago
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RE: A advertising a sum of its parts?

I think that all of this definitely should, and hopefully is, going through medical device reporting to the FDA. In my opinion, spending money and tim...

6 years ago
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RE: Fitbit Medical Device?

In correction to my last post, fitbit does not currently monitor blood pressure. However, what I wrote about applies to the physiological factors it d...

6 years ago
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RE: Meat without Murder

In response to AnmolKaur, MDR is very important. If a medical device is resulting in deaths or injuries, it needs to be investigated and potentially t...

6 years ago
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RE: Fitbit Medical Device?

Class 1 devices are intended for devices that require general controls by the FDA. At home blood pressure monitors are considered a class 1 device. Al...

6 years ago
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RE: Interpersonal Skills

As stated in Dr. Simon's lecture, leadership is 30% academic and intelligence based and 70% interpersonal skills based. While I do not have experience...

6 years ago
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