Both written and verbal can be very useful, but I would think that a verbal agreement should be followed up with a written agreement. A verbal can be good to work out the terms, but once on paper thos...

In terms of kickbacks, maybe a lot of these happen because some people may not think it is a big deal to accept to those things. Maybe it is just thought of as the cost of doing business in the field,...

This course has been very useful to show people what could really be expected of them when they get into the real world. It was good to see the different stages of developing a medical device, and wha...

The idea of the matrix organization seems to be a great idea for forming a project team. It will give the project manager an opportunity to really pick those people who may be best for that particular...

When working with people you may not know, that could be a good thing to allow for different ideas to come about. If you are not used to working with a certain person it may take some time to develop ...

The hardest part of a matrix based organization would seem to be getting people to be on their project team. If a person if involved in other projects it may be hard to coordinate with that person to ...

I understand that having to pay may just be the cost of doing business, but I do agree having a database would be helpful to those smaller companies. Some smaller companies may have such innovative id...

FMEA does sound interesting Roberto. By being able to make sure you device fails and then fixing those failures could be a way to have a stronger more reliable product. On the flip side, if you are un...

A meeting to determine if a project is a go or no go seems to rely heavily on the risk management. It seems like a good idea to have multiple departments involved in this process to fully identify the...

When it comes to outsourcing, it seems that it can be a very hard process. The company wants to make sure their vendor is doing everything properly when they transfer it over. This would mean their is...

I unfortunately do not have industry experience in a design review, but I can imagine how these meetings impact the development of the project. During these meetings it must also be important to stay ...

Meeting minutes are important to recap what was said or done in a meeting. I have been tasked with taking minutes, but I know that no one really read them. It would be just sent to the manager and upl...

It seems that design controls can be ever changing with how the device is developed over time. Reading over the previous replies, it is true that companies can not change the design controls forever. ...

A very important part of the DDP is the scope management plan. If the scope of the project is not clearly defined and kept in focus nothing will get done to move the project forward. Once people worki...

When the process is not used properly, it results in a failed medical device as stated by those examples above. In the case of those recalled medical devices, it would be interesting to know what thei...