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 ensure that the product’s risk is outweighed by the benefits. Ultimately, this topic falls under the ways in which risk is managed. I believe that…[Read more]

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 different risks with the device. A team is needed to not only identify each risk, but also be able to evaluate the risks as well.

-Andrew Nashed

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 verification. Looking through the site briefly it seems that much of the information provided is definitions and guidelines to allow for an engineer to…[Read more]

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 deadlines have been established. Oftentimes if meeting minutes are not taken these deadlines can be missed or people do not know the tasks that were…[Read more]

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 major difficultly in the design transfer. If an approved vendor can assist with a project, there typically is not an issue. However if a new vendor is…[Read more]

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 greatly delayed. The different areas of the Design Controls allow for each section of the project to be organized and ensure the product released is of…[Read more]

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 mentioned, it really outlines all the details that need to be completed by each member.

I would also say that the outlining of project meetings is…[Read more]

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, DID, etc. So almost all sections of the design controls are needed in the EU, but the full Design History File would not be…[Read more]