Communication is really the key for all project teams. Both communication between team members and communication between the team members and the project manager are essential to the performance of th...

In the lecture this week, it was emphasized that the entirety of the team working on the project is consulted when determining the duration of each task in the work breakdown structure. This makes sen...

I don't really think there is a way to spin it that missing a milestone on a project is a positive thing. I understand what you are saying, in that missing a milestone means you are in turn spending m...

It is imperative for the specifications in the design input document during the planning phase to be accurate and clear. In order to accomplish this, there should be collaboration from many different ...

The planning phase is the foundation for all other phases of the project to come. A strong and detailed planning phase is essential to the success of the project. As mentioned, customer needs are a la...

In the lecture slides this week, we learned about all things risk management. Starting in the planning phase, a part of DDP is to do risk analysis to determine the probability some undesired consequen...

Like yzs3 mentioned, sending the documents a week in advance could be very beneficial to allow for everyone attending the meeting to have time to read over and understand what will be discussed. In ad...

I don't think that any essential projects should be cancelled or even put on hold due to them being "less of a priority." This slows down the overall design process. Unless however, the project is une...

I think that the world is definitely moving towards one global system for regulations of medical devices. In addition, I believe that a global system of medical device regulation will have a plethora ...

In my opinion, the best time to carry out verification and validation steps would be consistently, as progress is made in the project. For example, on my capstone project, we are currently testing mat...

Specs of the product are essential in in the Design Specification Document to ensure that testing and development can be properly executed. The specs of the product must be properly documented to allo...

Properly selecting the members of a project team are just as important as any other step in the process, if not more important. A great product or device idea with perfect documentation and resources ...

This is a good question, that I wondered myself. It seems that there is a significant advantage in the timeline of developing a product if a product is labeled as class 2 rather than class 3. For prod...

Completely re-making the classification system seems very unnecessary to me. Granted I have no experience of using this for anything outside of this class, but I think that there are fairly specific q...

During this weeks "Mini-Sim" we were asked to select a product and decide the classification and regulatory pathway for the device. When I selected "Stop-Gap", the Left-Atrial Appendage Closure Device...