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 and how to achieve them. Although it may be a lot o...

Matrix organizational structures are more flexible in that you might have more flexibility with how you spend your time. With this structure, resources could be limited and there could be conflict if ...

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 begin working with someone you already know. Part of ...

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 the potential risks associated with that product. On...

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 identified and a plan is put out to deal with those ...

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 complex devices that has a very involved process. In thi...

Design inputs include customer needs as well as customer requirements. These are the aspects of the product that are expected to happen. For example, if you state that your product has a sensor that s...

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 discussed. Many times some things may be stated or decided...

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 needs a way of mapping out exactly how your produ...

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 general sense. This document is mainly targeted tow...

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 of tracing back and figuring how/what went wrong a...

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 accounted for in terms of risk management and that it pe...

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 might influence the distribution of the drug/ther...

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 something is happening, when it actually may not be....

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 something works in a mouse or rabbit, it will work ...