I believe that it is the responsibility of the manufacturer to notifying the user of any side effects or risks with the drug being administered. A study can be shutdown for several reasons, one being ...

Out of all my entire bachelors and masters courses there are only a handful of courses which gave me insight to what it is like to work as a biomedical engineer. AMDD is one of those classes, that mat...

The simulations are a great way to engage students into a work environment within the medical device industry. It allows students to apply the knowledge they gained within the lectures to real life sc...

The cost of a study is dependent on the location of the study, however, the prime reason for a study conducted outside of the U.S is not cost. The research must be associated with the region the study...

The first medical product that comes to mind when I heard of significant risk is a pacemaker. It is an implant which contains an electrical circuit that sends electrical impulses to the heart. My fath...

I never saw myself in the career path of clinical research due to the constant need for travel. I was interested in a period of time in the career path of research, so I interned within the human perf...

Recently, we received notification of a nonconformance within our instructions for use document which is sold in one of our major product lines. It escalated to a CAPA and HHE. A section of the docume...

From my experience, GMP (good manufacturing practices) quality system documents are general but clear. As a new employee, the company trains you on the GMP regulations that the company upholds. If the...

GMP represent good manufacturing practices, all medical companies have a list of regulations for there standards for good manufacturing practices. The company I work for has not updated the GMP qualit...

During my time at my company, I have not experienced a period when sales were on a decline. However, coworkers have told me what the company did in the past when the sales weren’t good. Upper managem...

The development phase is the most expensive phase within product life cycle. The development phase requires testing and creation of the products. Within an undergrad course that I took, we had to deve...

I have gone through the scenario where a project was to increase sales but in the middle of the project the marketplace was no longer attractive to the project goal. As a result, many meetings were sc...

My first project as a Biomedical Engineer was to obsolete a product line that was sold to Japan. Based off marketing’s decision the cost to produce the product did not match the profit compared to oth...

From experience, a project manager should be well informed of the current industry and market data that their product is apart of. The medical device industry is always growing and the need for medica...

When deciding to sign a contract with a customer you need both interpersonal skills and business knowledge. From experience working with suppliers, you need to be knowledgeable of the product, risks, ...