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...
I think that these restrictions are necessary because there is always someone trying to abuse their privileges or power to better themselves even thou...
This course has been extremely helpful in teaching me the background knowledge and divisions of medical device development. I learned about what divis...
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 o...
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 coor...
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...
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 ...
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 ...
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 ...
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 o...
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 u...
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...
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. ...
In terms of determining whether to perform validation or not, validation should still be conducted in order to keep better understanding the product, ...
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 ...