This is one of the main reasons I left a previous job, there was poor Human Resource Management. Sometimes there would be insane deadlines put on project deliverables and even if the employee worked e...

I completely agree with your point that using a supplier as a backup to itself doesn't make much sense. The point of having a dual source is to ensure complete independence assuming there are any prob...

I have had to source vendors several times at my work for different equipment and material needs. Sometimes all it starts with is a good old google search to get it going and find all the different su...

While project processes and design controls are not directly related, it is pretty standard that verification will be achieved through the executing phase of the large-scale project. Since verificatio...

In the medical device industry there are countless things which need to be documented according to the FDA which may seem monotonous but are all the same mandatory. My company was audited by the FDA f...

There are many obstacles to consider when attempting to ramp up something from prototype to mass production. Usually a Performance or Process Qualification protocol will need to be completed to prove ...

Money is one of the main driving factors for any project. Many people including investing stakeholders, upper management, and customers are all concerned with how much money the project is consuming. ...

Going with the category of mobile applications, food intake trackers would be considered general wellness products. Apps like MyFitnessPal allow you to log what you are eating and drinking in order to...

I think project managers are like a lot of different professions in that you are very specialized in certain types of projects. There are some universal principles such as the initiate, plan, execute,...

While some products age different than others, i think this results from how much innovation is possible. Sutures are very simple in that it is basically just nylon wire. There is not much that can be...

The FDA classification system seems fine for the most part. There have been previous issues with the "predicate device" exemption when companies try to base this off something that was developed more ...

As someone who has witnessed some design review meetings succeed and fail, there are some things you can do to ensure success. As @vcf3 mentioned, the attendees of the meeting have a high chance of ig...

Dr.Simon has mentioned multiple times the importance of this in his lectures. It is part of the project manager's responsibility to create a log of some sorts which details everything that worked and ...

I currently work in the manufacturing department of a medical device company. A lot of the principles from this class tie into what goes on in an everyday basis, but perhaps on a smaller scale. Not ev...

I sort of had a similar experience in Capstone as my group had to keep a detailed log of everything that was working out for us and more important what was not working. Our advisor let us find out for...