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Eminent Member
Joined: Jan 16, 2018
Topics: 0 / Replies: 39
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RE: Experience with Project Organizations

As a scout we had a very functional organization. We worked in patrols, we had an assistant Patrol leader and a patrol leader. They got together with ...

7 years ago
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RE: Pros and Cons of the 3 Organizational Structures

As a kid I was in the Boy Scouts. We had 4 different patrols, each with a Patrol Leader and his assistant, and then there was the Senior Patrol leader...

7 years ago
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RE: Your Ideas about How to prepare/write a Successful Project Proposal

I think there are pieces from every post before mine that are critical in what should be included. I agree, to an extent, with what all of you have ha...

7 years ago
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RE: Fitbit Medical Device?

I would still say no, the fitbit does not need to be regulated. The CDRH defines a general wellness product as “Products that are intended for only ge...

7 years ago
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RE: Product PMOA Classification with FDA Branches

Going in line with the example in the question, there are different coating on implants used to stimulate specific responses. For example the Hydroxya...

7 years ago
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RE: LifeVest Wearable Cardioverter Defibrillator

The Lifevest would have to be a Class III because it has the potential to save a life, though is a great risk to the wearer. Because the response of t...

7 years ago
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RE: Difference

I am a little torn on this. On one hand, I believe they are different and yet on the other I say not. Project managers are in charge of obtaining the ...

7 years ago
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RE: General Wellness Product

I may be going out on a limb here, but I think board games could be considered something of a general wellness product. It would be of the first categ...

7 years ago
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RE: Fitbit: A Medical-Grade Device?

I agree with what has been stated before me. I do not think the Fitbit should be considered for FDA approval; as it does not make any medical claim. T...

7 years ago
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