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es364
@31450849
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Joined: Sep 11, 2023
Last seen: Apr 17, 2024
Topics: 1 / Replies: 69
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RE: Sizes of Project Teams

I think that the success of working in large or small groups and with people from different backgrounds depends on the particular project, its objecti...

1 year ago
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RE: FDA classification for bme devices

It is very important to understand the differences between the three classes early on in a project because it can help save money and time. Typically,...

1 year ago
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RE: Difference between drug and medical device?

Drugs and medical equipment are very important for the safety of our health. Medicines and medical devices have many differences that may include thei...

1 year ago
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RE: Pre-market Approval (PMA) vs. 510(k)

Both the PMA and the 510(k) are the most important documents required by the FDA for medical devices to receive market approval. PMA is technically re...

1 year ago
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RE: When is giving gifts like the "old days" too much?

Gift-giving to doctors is a delicate and complicated topic, with different national and local laws and standards applying. In my opinion, it's fine to...

1 year ago
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RE: Restrictions for physician's gifts

This is a very good question. In my opinion, if you invite a physician to a dinner to talk about the product you can promote and they bring their spou...

1 year ago
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RE: Discussion Topic: Course conclusion and impressions

When I first started this class I thought it would be more of a medical device prescription class. However, I was surprised and at the same time happy...

1 year ago
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RE: Upper vs Middle Management.

Depending on personal preferences, professional aspirations, and strengths, one may choose between Upper and Middle Management. Some people are ideall...

1 year ago
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RE: Forming a Project Team

Establishing a project team is an essential first step in making sure a project is successful. Creating a project team that works requires a deliberat...

1 year ago
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RE: Organization Type vs. Effectiveness

In my opinion, the best organizational structure is the matrix organization. I think this way because the resources in this type of organization are v...

1 year ago
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RE: Discussion Topic: Risk Management, Risk Analysis

ISO 14971 is the primary ISO rule that regulates risk management for medical equipment. ISO 14971 is a worldwide standard that offers a framework for ...

1 year ago
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RE: Ways to deal with risks

An example of avoiding risk is when a specific substance used in the urinary catheter was found to have the potential to cause allergic reactions in c...

1 year ago
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RE: Risk Assessments are necessary or not for medical devices?

Risk assessments are required for medical devices. The regulatory framework for medical devices must include risk assessment as a fundamental element ...

1 year ago
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RE: Corporate Responsibility?

Like most of the comments, I believe that companies are taking their corporate responsibility very seriously. Companies are now expected to conduct bu...

1 year ago
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RE: Gantt Chart Thought Process and Considerations

To guarantee an efficient project management procedure, a number of elements should be taken into account when arranging tasks and generating a Gantt ...

1 year ago
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