An NDA is an acronym for a non-disclosure agreement. This type of agreement refers to a contract in which the parties involved will keep information shared between them confidential to others. This contract can be applied to court and possible…   Read more»

There is a difference between a contract and an agreement. An agreement simply refers to parties agreeing to do an action while a contract includes the agreement but is legally binding and can be part of a law suit. With…   Read more»

I believe that this type of regulation is necessary in order to achieve a certain level of fairness. In general, we don’t want the company to buy the doctor so I believe that this is fair to have this limit…   Read more»

I think that the problem with this question is that there is already a set difference between the different departments. This creates a separation between the employees and researchers which can cause problems. I believe that there is importance in…   Read more»

I think that culture and structure influence each other but they are separate entities within a company. Culture is more of how people work and interact with each other while structure deals more with factor such as who they are…   Read more»

For me, at this point in time, I believe that I am currently more suited for Middle management. Although, it would be ideal to be the people who start projects, I think that I have not gained enough experience to…   Read more»

I agree with those who believe that project managers will have difficulty completing work in a matrix company structure. This is because of the presence of another project manager who the employee has to report to. This adds complications because…   Read more»

When building a team, first and foremost, it is important to pick a teammates that are good at working with others and is able to motivate the other members. It’s not good to have a members that are not open-minded…   Read more»

Each organizational structure has its own advantages and disadvantages. So when initiating a project, it is important to figure out the benefits of a structure in order to take advantage of its benefits. In terms of collaboration, it would be…   Read more»

As the standard states, the company must, to the best of their ability, reduce the risk to the lowest level possible. I believe that this could be done by being able to address all the issues present in the device….   Read more»

Risk identification is an important aspect of medical device development. It is better to prevent than to fix because fixing implies that damage has been dealt. Risk identification is part of risk identification, which is the mitigation of the potential…   Read more»

Risk management is an important aspect of business in order to have a successful product release. In terms of assuring that the final device run smoothly, these risk management meetings must occur on a constant basis. Problems arise throughout the…   Read more»

I believe that even though it is not required, it is important to point out that performing the validation process can do more benefit than harm. Although it may add to the costs, it would be better to do because…   Read more»

Design controls are important because they keep the product up to standard and up to date and competitive with other products. Sub par products can turn out to become dangerous and deleterious. This can be avoided by having strict design…   Read more»

I completely agree with the points mentioned above. An effective product is the fruit of good design controls and other properly implemented steps. Just as every ingredient is important, a good verification process ensures that a product will work based…   Read more»

Meeting minutes are important. You possibly can’t remember everything in the meeting and your personal notes will only show the thoughts you had in your head during the meeting. The minutes are important because it’ll allow you to go back…   Read more»

When making any schedule, it is important to note the schedule of other people who are involved inn the project. It is important to keep in mind that they also have deadlines to meet and things to do. Furthermore, it…   Read more»

I think that having double blind experiments are beneficial in their way since it reduces the possibility of a bias from both the subject and the administrator. This ensures that the results read in by the administrator is not tainted…   Read more»

Consent, in terms of medical trials and treatment, is important because of the possibility of law suits and numerous liability reasons. In terms of possible clinical trials and each individual’s choice to contribute to science, it would be beneficial to…   Read more»

Placebo trials are important because they create a data point which can be used as a comparison point for the results of the other administered trials. A placebo trial can be compared to experimental set-ups as the control experiment. This…   Read more»