I have not even had to identify risk perspective from that large a range before, but I have seen different perspective about risk in my team. I worked on a project where the team leader main concern w...

I worked on a project where we had to collaborate with a different company or our validation projects. Because I was more familiar with the system and they were basically adding to our current system ...

I currently work in the pharmaceutical industry, most of the projects I work on was around building up our current labs to GMP standards. However, I had work of several different project with differen...

I also agree that the culture of the group is very important. It can get off to a rough start if the initial team is not very compatible . This is especially true when the project is ongoing or will b...

In the event that you are modifying a device to the point where you may need to have software modification, it will need validation. If it is a modification that do not need animal testing but may sti...

In worked on a med-device for soft bone injuries that that I built with a group of 4 people. The design was based on a modification to a cam walker boot. The design was already similar in physical tra...

Intellectual property is one of the most important things to consider protecting when making an agreement. The contract should consider the benefit and risk of both parties and should be very clear in...

I think the matrix organization is best simply because the advantages are centered around multiple control. There always a second opinion. Thought that can be difficulty to deal with sometime and may ...

I would not form a team based just on personal relationship. I would form a team based of the individual that best understand the objective of the project. Most people in industry can adjust themselve...

When working on projects where other companies are involved. I think that the most efficient type of organization is the functional or matrix organizations. I think that is important simply because ev...

There are many ways risk are identified and dealt with in a company. In every department there are different risk factors that are considered for different perspective and that are sometimes only appl...

I think that avoidance is of the lowest severity simply because the problem is not his, however depending on the drawback to that product function it can be a difficult decision to make. I think that ...

I think that is anything in industry can easily lose its real purpose in the face of company agenda. Risk management should exist to insure that the used is completely safe and hot harmed at all by th...

I believe that meeting minutes are extremely important, even so that there is a person at my job that would take notes during the meeting and then type it up afterwards and send it to everyone. I have...

In agree that the FDA may be more interested in insuring that the design controls for a specific device is within the FDA standards. For example, when a company send in a new IND to the FDA for a new ...