I believe that the DHF is more useful than the Tech File/Design Dossier. The FDA is highly concerned with a company’s DHF because it involves everythi...

Although it is easy to mix up the concepts behind design verification and design validation, both of them consist of different aspects that ultimately...

I agree with the students who believe the DHF is a living document. If any change is made to the medical device, the information should be included in...

The answer that I am about to state is based on the links Dr. Simon posted on this week’s lecture and my understanding of the documents. The Guideline...

Hi Fady! I do not have experience with filing combination products in the EU. However, in my opinion, it seems like a major hurdle would be choosing ...

After listening to the lecture, it is clear that it is easier to get devices approved in the EU for several reasons. The EU bases their classification...

I do not have any experience with working with PMOA for a combination device. After doing research on this topic, I have come to the conclusion that i...

Hi Fady, You made a very excellent point because there is definitely a greater chance of data distortion if too many centers are present. Variability...

Hi Andrew, Unfortunately, I do not have any experience in this area, but I do agree with Dr. Simon’s lecture on getting in touch directly with the le...

I do not have any similar experiences to the one you provided, but I can definitely say that it is an interesting one. The situation does in fact viol...

As other students mentioned in their posts, a written agreement is considered a legal binding document, and thus, the agreement is essential if the ma...

Undoubtedly, this course was incredibly beneficial and a great learning experience. Before enrolling in this course, I did not hear much about the mat...

I would choose to startup the company with a Matrix organization. This type of structure would be the most beneficial because the project manager hims...

Hello Lamiaa! That is a very interesting question. It would be more challenging for the project manager to work in a Matrix organization. As mentione...

Currently, I work in a functional organization structure. In the research and development department, engineers are required to work on a certain proj...