If you are going to begin spending money and time on a project I would take the precautions of ensuring the agreement is written so if your funding decides to pull their resources or not collaborate with you for the…   Read more»

As an undergraduate student who is graduating next semester, I found this score extremely useful. This class was my first exposure to the field of industry. No other class has covered the different departments available within industry. At first glance…   Read more»

As Saad has mentioned I feel for most companies matrix based organization would be the most beneficial. I say this because your resources (employees) do not become redundant and the project manager can hand pick individuals from different departments within…   Read more»

We can all agree that it would be ideal to have a knowledgeable team with a good relationship. However I feel as a project manager when picking a project team you must ensure your team members are qualified and knowledgeable…   Read more»

Both matrix and project based organizations have their advantages and disadvantages as a project manager. As a project manager I feel a significant factor in finding success is being able to create a harmonious work environment where everyone is on…   Read more»

I can understand where many of you in this discussion are coming from, however I am going to have to respectably disagree. Although it is the responsibility of the company to ensure that they have minimized the residual risk of…   Read more»

At times it is very unlikely to be able to eliminate all risk in a medical device. The article posted above does a great job explaining what “as far as possible” implies in the IPO. This just ensures that the…   Read more»

For low severity risks you are either going use acceptance or mitigation. You are going to have to determine if the benefit is worth the risk. If the benefit is worth the severity of risk you are taking on you…   Read more»

There has been very good points made as to the benefits of large and small companies outsourcing for their design transfer into manufacturing process. I agree that small companies will often benefit from outsourcing the manufacturing process because often times…   Read more»

The verification and validation reports provide evidence for a company that their product inputs will directly lead to the product output. In order to confirm this is true you must design a test to validate the claims. These tests that…   Read more»

Although I have not yet been involved in a company meeting where meeting minutes were documented I can see why Dr. Simon has stressed the importance of the minutes in his lectures. These meeting minutes help document all vital information…   Read more»

As our classmates have previously mentioned lapses in the design control benefit no one and are just dangerous for the consumers. As a company manufacturing and distributing novice medical devices coming in contact with human subjects must guarantee safety. If…   Read more»