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ms2768
@ms2768
Trusted Member
Joined: Sep 7, 2022
Last seen: Apr 27, 2024
Topics: 2 / Replies: 74
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RE: FDA classification for bme devices

It is always important to know the distinction between the three classes, as stated multiple times in the lecture and the mini simulation because it c...

1 year ago
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RE: Project Management Information Systems

It is extremely vital to ensure that project progress is met for the project timeline to not be delayed or impacted at all. While ensuring that projec...

1 year ago
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RE: Reclassifying Medical Devices

This is a very interesting topic because how possible it is in the "real world" for industries to experience something like this during projects. Base...

1 year ago
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RE: Funding in Medical Devices Industry

While many have stated that the company should fund the project and go for the patent, the initial post only says that the project idea has a potentia...

1 year ago
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RE: How to increase emotional intelligence

The part of the lecture that focused on emotional intelligence and social skills really stood out to me and made me want to start reading the novel th...

1 year ago
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RE: Sizes of Project Teams

I found it very interesting reading the different opinions and experiences of others that have been part of project management teams. From my personal...

1 year ago
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RE: What are the limitations and protections of trade secrets?

I find the point of another company having the same product without breeching any confidentiality violations very interesting. From the example provid...

2 years ago
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RE: Confidentiality Agreements

As discussed in the lectures, the CDA and NDA will have all the basic parts that a contract would have. These would ofcourse include all the basics fo...

2 years ago
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RE: Project management

I believe the best way to think about the Design Development Plan is as a complete lay out of blueprint of the project. The basic documentation and pl...

2 years ago
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RE: For those that work in a matrix based organization:

I work at a matrix organization based medical device company and I can see how it could be over-whelming being on multiple projects, especially for th...

2 years ago
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RE: Desicion made by one person

I believe that even though there is one official person making the decisions, they still have their personal assistance from other professionals aroun...

2 years ago
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RE: Risk Management Process

While I have not had direct experience with risk management or the scenarios you mentioned above, I think the examples in the lecture (using a scalpel...

2 years ago
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RE: Getting Everyone's Input in Risk Management Meetings

I currently work at a medical device development company in the industry and am going to be attending my first risk management meeting in the near wee...

2 years ago
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RE: US FDA vs EU MDR Risk management

This is interesting because based on the lecture, I thought that ISO 13485 was the medical device ISO standard, meaning that USA also follows this sta...

2 years ago
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