I would prefer middle management because you are more directly involved in the projects that happen. You have a better idea of what needs to be done a...
Matrix organizational structures are more flexible in that you might have more flexibility with how you spend your time. With this structure, resource...
It always works out well when you really get along with the people in your groups. However, there does need to be some ground rules set before you beg...
Once the meeting is set up and the purpose and function of the device is fully understood, it would be a good idea to have a group discussion about th...
I think one reason why companies get risk analysis wrong is because they know it requires a lot of work. What I mean by this is that once risks are id...
One technique for risk analysis that I came across is a bottom-up approach called HAZOP (Hazard and operability). This is usually used for more comple...
Design inputs include customer needs as well as customer requirements. These are the aspects of the product that are expected to happen. For example, ...
It hasn't happened to me personally, but recording the minutes of each meeting allows everyone involved to be on the same page about what was discusse...
The purpose of Design Controls is to prove to the FDA that the product has all of the necessary requirements for being released to the market. The FDA...
Each document serves a different purpose. The DID gives a broader view of the product, outlining certain indicators and/or how it will function in a g...
If there is no way of mapping out how the device was made, the effects can be very detrimental. If something were to go wrong, there needs to be way ...
Design controls are a way to prove that you have done everything according to the procedures outlined by the FDA. It ensures that everything is accoun...
I think the point of a double blind study is that it eliminates any biases. The researchers and doctors might expect or wish for a certain outcome and...
Placebos used in studies are useful because they act as a sort of control. As stated previously, the brain is very powerful and can allow you think so...
Clinical trials are necessary in order to further advance the final product. As Professor Simon stated in his lecture, you can't assume that because s...