From recent training received at my job we were always told that gifts shouldn't be higher than $50 dollars and should be able to be shared with others within the company or benefit the tasks needed t...

During this week's lecture, Advamed guidelines were briefly discussed. One guideline that stood out to me was that sponsored held events must be held at a reasonable location. When thinking of places ...

This week, we learned about the legal basics in the medical device industry, one specific topic was the significance of both verbal and written contracts. Given that most contracts are required to be ...

Maintaining a balanced working relationship is crucial. While prior experience with a team member from a past project can facilitate the initiation of a new one, it is extremely important to ensure th...

Before addressing your question, I agree with your statement that being part of middle management can provide a solid foundation for an upper management position. Personally, while I am confident in m...

After being assigned to our project groups about two weeks ago, which organization structure (Functional, project-based, or matrix organization) do you think will benefit your group and the device dev...

I actually questioned this myself this past weekend when creating the DID for the project Dr. Simon has assigned to us. Personally, I feel as though regulations should not cost since these regulations...

This week we learned of 4 ways to deal with risks: avoidance, mitigation, acceptance, and transference. After learning the difference between the four, d0 you think risk acceptance creates a higher pr...

I currently work in an in vivo lab and can think of several hazards in a hazardous situation with a specific harm. We often have certain test subjects that undergo doses of radiation and other test ar...

@vnd4 If verification test usually stay in house, do you think there is a specific department or procedures that ensure that this verification methods are suffice? I'm aware that inputs and outputs mu...

This is sort of off topic of correcting specific documents such as DSD and DID but I wanted to mention the practices in Good Laboratory Practices (GLP) regarding data collection. In GLP, when errors o...

Device trials are different in several ways when compared to drug trials such as: 1) medical device trials are usually smaller than drug trials. 2) Physician technique or bias is a larger role in drug...

There have been lots of good points mentioned on the benefits of outsourcing or stay in house. The main point that was made is if it is cost effective for a company. I think staying in house is always...

During this week's lecture different types of documents were discussed such as DID and DSD. When there is a error found in these different types of documents is a change request issued? Or are there o...

I agree that meeting minutes are important and that people usually don't pay as much attention as they should to them. I also think meeting minutes are more important to those who were unable to atten...