If you were to have ownership of a corporation, which type of corporation would you want to be an owner of? a. Sole Proprietorship b. Partnership c. Limited Liability Partnership d. Limited Liability Company e. Running Corporation f. Corporation (S…   Read more»

Based on your work experience in any company, what were some issues you found with the quality department and how would you fix them? For example: I work in the manufacturing department of a medical device company but all of…   Read more»

Name a combination product which is currently on the market such as a drug releasing stent. Specify the primary mode of action and department you believe that the device should be under(CDER, CBER, CDRH). Explain. Based on your selection, layout…   Read more»

Based on this week’s lecture there are numerous differences on how research is approached in an academia compared to industry. Name two ways that research is approached in academia versus industry. Out of the two approaches which one do you…   Read more»

Give an example of a time when you encountered an obstacle while working on a project that could have resulted in not reaching the deadline. What phase of the project life cycle should you have focused on more to have…   Read more»

This week’s lecture discusses the different phases within a project life cycle; initiating, planning, executing, monitoring & controlling and closing phase. Which phase of the project life cycle do you think is crucial to the success of a project? Explain….   Read more»

For those who have work experience in the medical device industry, what advice would you give to Biomedical Engineering students? What would you have wished you would have done differently as a student to help project your career? For example,…   Read more»

Risk Management is necessary when dealing with medical devices. Many companies have different ways of evaluating risk within a project such as using a pFMEA, FMEA or FMECA. There are four main ways to manage a risk: 1. Mitigate 2….   Read more»

If you have ever participated in a design review meeting please share your experience on how it was in comparison to how you expected it to be. What would you change on the way the design review meeting was conducted?

There are numerous monitoring and controlling techniques which were mentioned in this week’s lecture. Which technique do you believe is the most essential in this phase of the design control and explain why? If you know any other techniques on…   Read more»

Companies have different procedures in order to submit a design change request. Share your experience on the steps needed to complete a design change request at your company. At Maquet, the engineers redline the latest version of a document as…   Read more»

In the process of creating a medical device risk management is required by the ISO 14971. Find an article on a medical device of your interest and summarize: 1. Access the possibility of one specific risk of that product 2….   Read more»

According to the FDA, a combination product is the combination of a drug and a device. It can include two or more dependent products either packaged together or separately. An example would be an insulin injector pen which diabetic patients…   Read more»