I would agree with Dr. Simon that it makes sense why labeling would not be considered a strong way to mitigate risk. While warning and instruction labels are important, it is also up to the company to...

Thank you very much for the interesting question. I would agree with Tarek that determining the risk associated with a project is a team effort. Each member of the team may be able to evaluate differe...

Hi Roberto, After doing some research, I was able to find that the FDA does not demand specific tests, but establishes guidelines for developing design controls, design validation, and design verific...

Hi Roberto, Thank you very much for your question. I would agree with Dr. Simon that meeting minutes are extremely important. I have been in meetings may times where tasks have been assigned and dead...

Hi All, I wanted to elaborate a little on a point that was made about the difficulty of the purchasing department not not having enough time to identify and approve new vendors, as this can be a majo...

Hi Lamiaa, Thank you for your questions and the examples provided by the others. I believe that one main issue that would occur is that the project would be extremely disorganized and would be great...

Thank you very much for your interesting question. I would agree with Tarek that it is difficult to choose which area of the DDP is most important, but the Gantt Chart is extremely useful. As Tarek me...

Yes, Design Controls would be needed for a medical device in the EU. While there would be no DHF needed in the EU, most of the parts of design controls would still be needed, such as the: PDF, DDP, DI...