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 and restrictions in…   Read more»

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 market can be controlled by persuasion through expensive…   Read more»

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 divisions such as Regulatory I would not enjoy…   Read more»

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 our projects overlap our when we…   Read more»

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 must structure your project around other department…   Read more»

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 better prepare you…   Read more»

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 occur. Then once…   Read more»

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 out standards and who provides safe…   Read more»

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 level to a…   Read more»

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 project leader who will open…   Read more»

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 verifying that the device…   Read more»

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…   Read more»

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 and DSD you may run…   Read more»

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 completed as well. Even if there were no changes to…   Read more»

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 steps that you take in designing and…   Read more»

Placebo controlled trials are ethical if the individual who is not receiving the correct treatment, is not in serious danger regarding their health. They are also ethical because all individuals have to sign an informed consent form beforehand, agreeing that…   Read more»

I believe obtaining informed consent in any medical setting or research setting is very important and necessary. Doctors and hospitals are meant to help and assist patients not secretly be using these regular patients who come to them for their…   Read more»

When it comes to handling clinical research I think it is a necessity to have some sort of clinical background or to have undergone a period of clinical training and observation before you can be in a clinical setting. As…   Read more»

Some ways that company’s are engaging in Participation is through surveys, questionnaires, and special deals for customers. For instance, after you visit a company’s website, buy a certain product online or fill out a form on a company site, they…   Read more»

I believe that when it comes to marketing, manipulation is the key component to success. Most customers at the time do not know that a product exist, do not know why they should buy the product, or do not know…   Read more»