I believe there is a huge different in a written agreement and verbal agreement. In a verbal agreement anything could be said and there is really no true follow-up or verification for the agreement that occurred. In a written agreement…   Read more»

The matrix organization is my preferred method to work in. This allows everyone to work freely and information is easily shared between project teams and members. I believe the power is not focused solely on a manager and the team…   Read more»

I think it would be best to work with people that have knowledge and specialize in specific areas. They can bring there knowledge and work together on project. The different aspects will help prepare the team. Of course key tools…   Read more»

In order to identify the risk you must brainstorm and predict the risk before they occur. You must evaluate the safety and effectiveness of the device. This will help you or a team identify the risk. You may also compare…   Read more»

Each risk management tool is important. In the past I have used the brainstorming tool. When working with others or alone brainstorming was implemented. We came up with ideas that include the limitations of the risk, and also thought of…   Read more»

The risk benefit analysis is important for medical devices that are developed. The benefits need to outweigh the risks to have a safe and effective medical device. The risk benefit analysis will determine the availability of a product. If the…   Read more»

To have a successful validation there important aspects to the validation. These key components include making sure that the design control and process is verified. Another aspect is making sure that the customers and the medical device company demands have…   Read more»

I believe the customers input is the most important section. I believe there input could validate sells as well as marketing. While designing the device you can know what to target and focus on to accommodate the customers. You also…   Read more»

Even if we have passed the verification phase, I believe that if human subjects are involved there needs to be validations. They could change some of these requirements due to humans being involved. If everything is not validated then its…   Read more»

The advantages of clinical studies include discovery of new medications, devices and treatments. This could include fewer problems or side effects of current treatments. A new medication may also work stronger and faster than a previous medication as well. Finding…   Read more»

I believe being a Clinical Research Associate should require a clinical background. I believe that clinical research involves being hands on with lab equipment, or subjects that are involved within the clinical trials. The trials could include animals or humans…   Read more»

I believe that human subjects should be exposed to life threatening clinical trials when there is a life alternating, or dying disease available. I believe that this is a sacrifice of the small for the many. Thousands of people could…   Read more»

The color that I notice for most companies or businesses is the color blue. In general blue has a positive impact. Examples include water, or the sky which represents calmness and tranquility. This color positively affects the mind body and…   Read more»

In order to recruit I would really dive deep into the community and interact with people within the community. Listen to there issues and try to relate to them. I would inform them about the impact that they would have…   Read more»

This is a great question. Me personally being fresh out of college, after completing my undergrad I would not turn down a job based on label of the company. I believe that at the entry level all jobs should be…   Read more»

On average there are around 50 to more recalls in a year within the medical device industry. I have heard about the Abbott cardiac pacemakers recall. There were over 400,000 devices created and sold. The device had issues with exposed…   Read more»

Other countries including India, have certain drugs that are not banned. There drug laws and policies are different compared to the United States. Within the United States the safety and effectiveness of drugs is taken very seriously. They ensure that…   Read more»

I agree  with the initial statement made regarding this topic. I believe that all medical devices should be assessed at there own merit, especially due to advances in technology. However, I do believe when medical devices are being developed, they…   Read more»

I believe the line should be drawn for certain animals. In this case I believe these animals include pets such as, dogs, birds, and cats. I do believe apes should be experimented on, because they are the animal that closely…   Read more»

There are many differences when as it pertains to the Academia and Industry department of medical devices. First the salary is higher for the industry department by a huge margin. The Academia department also has to fight for grants to…   Read more»