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 everything from risk analysis to an end product where prod...

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

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 DHF. If a certain part of the device is alter...

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 Documents are not mandatory, but they certainly p...

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 a Notified Body that is capable of evaluating combi...

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 on an essential requirements checklist and on ris...

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 if a company cannot identify a PMOA, a Request for ...

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 needs to be controlled and in order to do so, the ...

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 legal department in order to expedite the process of ...

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 violate the NDA or CDA for multiple reasons. The consu...

As other students mentioned in their posts, a written agreement is considered a legal binding document, and thus, the agreement is essential if the matter gets taken to court because all parts of the ...

Undoubtedly, this course was incredibly beneficial and a great learning experience. Before enrolling in this course, I did not hear much about the material, and initially expected to learn about the t...

I would choose to startup the company with a Matrix organization. This type of structure would be the most beneficial because the project manager himself can choose employees from different department...

Hello Lamiaa! That is a very interesting question. It would be more challenging for the project manager to work in a Matrix organization. As mentioned in Dr. Simon’s lecture, every member of the staff...

Currently, I work in a functional organization structure. In the research and development department, engineers are required to work on a certain project without input from the quality engineers until...