It is important to consider the hazard and hazardous situation as aspects to be evaluated separately because of the difference between how a person is. Hazard is considered the source of harm where there is a possibility that something, such…   Read more»

Internal risks are risks which are controlled and start from the inside of a company while external risks are risks which are not as controlled and start from the outside of a company. With internal risks, there may include mistakes…   Read more»

Some critical characteristics of the risk profile of a medical device includes the devices intended use, the class of the device (I, II, or III), which also represents the potential harm and invasiveness, and the components of the device. The…   Read more»

I myself have not seen any companies that do this because I have yet to work in industry but I do know that this is considered to be very unethical. The verification process when working on a design is used…   Read more»

Teams can decide when they have done enough reviews after meeting multiple times throughout the design process course. By doing this, the team can have time and opportunities to go through all the risks, meet the user/ customer requirements, and…   Read more»

I have not worked in industry yet, but I learned a lot about the difference between verification and validation through the FDA course I took last semester then again during this course.  I also expect to see it resurface in…   Read more»

A team should really aim towards making their user needs balance and come hand in hand with a businesses goal. The point of being the engineering behind the product and project is to meet the business goals while also considering…   Read more»

It is necessary to have both the verification and validation processes separate because they are intended for two different things. Validation ensures that the device is the correct product for the user, while verification guarantees that a device is built…   Read more»

I believe that when it comes to taking meeting minutes its essential that way, when referring back to what was said in the meeting, it is clear and concise. It also helps when needing to gain an understanding of what…   Read more»

The purpose of clinical testing is to decide if a drug is safe and effective enough to treat a certain condition. Drugs function by affecting biological functions within the body. Clinically tested drugs have the ability to reduce disease development,…   Read more»

By finding multiple volunteers from all different backgrounds and making enrollment goals meet these standards, companies can ensure that their study patient group is as needed and expected. By using volunteers from different races, ethnicities, ages, sexes, as well as…   Read more»

When comparing results from a group that receive test drugs and a group that are given the placebo, the placebo effect can be differentiated. It is happens to be that the two groups exemplify positive results, then those working on…   Read more»

When developing a company to manufacturing dental tools, I would sell them to dentists themselves, dental retailers, and dental clinics/ offices. Because dentists are the primary users, selling to them directly could impact the way the company manufactures the tools…   Read more»

I have noticed that different industries typically lean towards certain colors in their branding.  For example, green is usually used for biological, natural, and health brands while blue is used for medical companies because its a color that symbolizes professionalism….   Read more»

Physicians should be compensated for their time and skills when it comes to testing or developing new and upcoming devices but not regarding the number of devices sold or referencing it to be used.  This is essentially because, no matter…   Read more»

The type of company would not be the reason I turn down a job rather the type of financial situation they are in, who the owner is, the ethical and moral standing of the company, my ability to grow there,…   Read more»

I believe that it is smarter for a new business to begin small and simple rather than trying to become a corporation from the beginning. If one starts by having a simple structure then they can build on it and…   Read more»

Having sole proprietorship means that there is only one, single owner because it is legally just owned by one individual. If the owner of the company chose to hand down his business then he could without having to start a…   Read more»

I think that medical-device companies should enforce one unified quality system across all region because then there would be less variation regarding the testing of devices along with how they are actually made. This just makes everything more consistent and…   Read more»

QA, quality assurance, is a process which aims at preventing any possible issues that may be ran into during the project while ensuring that quality standards are met with the production and device design.  QC, quality control focuses on identifying…   Read more»