When forming a project team, I would stay away from nepotism. I would rather let the work and personality of a person gain them a position on my team. If I ensure this, I will have a greater chance of…   Read more»

Project Organization is the type of organization that would best suit my talents. With this type of organization, people are able to gain knowledge from other members and I absolutely love this for two main reasons. One, I enjoy learning…   Read more»

With my personality and  unique talents, I would be better suited for Upper Management. I am a very analytic and strategic person, making sure I have a plan before I do anything so as to be prepared for most situations….   Read more»

The risk management file is a living document that includes all of the information pertaining to the risk management process. It is important that this is updated regularly because changes occur often and should be noted. 

In my opinion, I do not believe it is ever okay to accept any amount or level of risk when it comes to medical device development. This is a very specific area of device development that involves the health and,…   Read more»

Risks are situations or possible scenarios that lead to the a delay in production or a failed project or design in the end. In order to mitigate these risks, I would first identify then prioritize a list of risks. This…   Read more»

While drug trials and medical device trials are similar in a few ways, they are also different in just about the same number of ways. First of all, they have vastly different routes to assist and/or alleviate pain. With drugs,…   Read more»

Yes, after sitting on an executive board in undergrad and taking the minutes as secretary, I understand firsthand how important minutes are and why they are this important. The minutes are taken for various reasons, like being a good point…   Read more»

Design Controls can be viewed as the checks and balances seen in the political world. This system is a set of procedures that are put in place to ensure an efficient and effective design or product. This is important for…   Read more»

A few of the advantages as it comes to clinical studies are the marketing and the treatment. The marketing side comes from the word of mouth distribution coming from the subjects regarding their results and experiences. The treatment can pose…   Read more»

I believe placebo trials are ethical, but not necessary. The ethics behind PCTs are reasonable and do no harm to the subjects. However, the necessity a of placebo is not clearly defined. The advantages are that no one is harmed…   Read more»

From an ethical standpoint, it is acceptable to expose humans with their informed consent and  knowledge of test trials. Th first group is usually healthy humans who give their informed consent. I believe that those who enter study and test…   Read more»

The answer to this depends on the type of business and the personnel. I the business is small and there are one or a few workers, I would recommend either a sole proprietorship or a LLC/LLP. If there are high…   Read more»

Yes, I would turn down a job based on its type. The two main criteria I would base my decision on are the financial history and the company’s reputation. The two factors are important because the financial history will allow…   Read more»

The difference between a public and private company is that the public company has shares that can be bought and traded via the stock market. A pro to this is the possible financial gain for both the company and the…   Read more»

I believe keeping a relevant knowledge of new technologies is the same as any field: continue reading research and engaging in new educational classes or forums. I think continuing ones education in a particular field, whether it be through talks…   Read more»

I believe keeping an open line of communication and having an understanding among the various departments is key. I do not think that this level of checks and balances should cause any confusion or bring about any bad relations between…   Read more»

Just as important as the planning phase of any project or product, the quality of said product or project is vital. Without a quality assurance or control team, a medical device could be faulty without the attention or knowledge of…   Read more»

I do not believe this is unethical because strict regulations are in place to prevent this from happening. The only alternatives are humans or human-like systems that would be constructed models. If people believe using animals are unethical, I do…   Read more»

I agree that communication needs to be a foundation to the solution so that an understanding (not necessarily an agreement) can be reached. After both sides listen to and understand the other side’s point of view, arrangements should be made…   Read more»