Yes I think that there is a difference between a verbal and a written contract. A written contract can be more in depth where one party will take more time and room to outline some rules, agreements a...

I think that these restrictions are necessary because there is always someone trying to abuse their privileges or power to better themselves even though they will be hurting other people. If the marke...

This course has been extremely helpful in teaching me the background knowledge and divisions of medical device development. I learned about what division I would enjoy the most working in and what div...

I work in a functional based organization where I work with only other quality engineers. We coordinate with each other on our own projects and will only reach out to other organizational groups when ...

I think it would be more challenging for a project manager to work in a matrix based organizational project. In the matrix based project you must coordinate with other functional departments more and ...

For me personally I think I would be better suited for Middle management based on my experience in the medical device industry. I think to be in upper management you need a lot of experience that will...

In order to run a risk management meeting I think the risk manager must first take time to assess all possible rise, give them a severity ranking and point out areas where risk are more likely to occu...

I think that these regulations cost money because they provide a platform that companies can use, where if they follow these guidelines, they will be recognized as a company who abides by these set ou...

Based on the options for Risk Management, choosing mitigation would be my selection for a low severity risk. If the risk is not severe there can be a way to mitigate the risk to reduce the severity le...

From my experience working in the medical device field I have had to sit on design review meetings that dealt with going over the validation process of multiple documents. The meetings are run by the ...

I believe verification is important because it makes sure that the device you are creating is exactly as you intended it to be, so that there are no unanticipated problems that may occur later on. By ...

The advantages of having each document is that it gives the team time to plan out their design study and to get a general idea of what they need their product to be. With the DID the team is able to f...

Some potential problems from not following the design controls process and using the process wrong is to have major delays or changes in your device. By being too specific in documents such as the DID...

In terms of determining whether to perform validation or not, validation should still be conducted in order to keep better understanding the product, and that human factors evaluation should be comple...

Design Controls are a critical component of every project and provide the necessary checks to ensure that all devices are safe for use and meet their intended use. Design Controls will monitor the ste...