I also found these restrictions to be quite ridiculous, especially not being able to pay for the physicians spouse. However, I do understand why these regulations are in place and what they are preven...

Although recognized as a legal contract, I personally do not think verbal agreements, especially on behalf of a company, should be used. As Professor Simon had also mentioned in the video lecture, the...

Being that the only experience in industry I've had is the position I currently hold at a medical device manufacturing company, I found this course to be immensely helpful and somewhat like a roadmap....

I agree that the size of the company and the product being produced plays a large role in deciding which is the best organizational structure. For smaller companies, I can see the benefits of having a...

The medical device development company I currently work at has a functional organization type. As Professor Simon had explained in his lectures, this is where the company is structured into department...

Although it is rare you are able to directly chose each individual on your entire project team, I believe a diverse group who holds expertise in varying departments is necessary for a projects success...

When identifying and analyzing risks, there are tools that can be used such as brainstorming, failure mode effects analysis (FMEA), fish bone diagrams etc. to help lay out why the risk is present, how...

Within the risk management process, there are four stages which include analysis, evaluation, management, and measurement. Once we have identified and categorized each risk in the analysis, assigned p...

There are four ways to manage risk: avoidance, mitigation, acceptance, and transference. Transference is basically transferring the risk elsewhere and not commonly used in medical device development. ...

Dr.Simon’s stress on the importance of meeting minutes is for good reason. To begin, meeting minutes are an all encompassing record of what took place during the meeting. This can include the date and...

I agree that one way to keep the DHF audit ready is to ensure the document is “living” and accurate to the product currently being produced. Although, I would like to bring up some of the risks associ...

Design controls are an elemental piece of getting a well-thought out idea on a piece of paper to a manufactured reality. Design controls include nine parts: planning, input, output, review, verificati...

Although I have not had the opportunity to prepare a Gantt Chart for the company I work at in industry, I did have to include this in my senior design capstone proposal and got a brief introduction in...

Outsourcing the design transfer can be beneficial in many ways, such as cost efficiency or a shorter time to market. However, and possibly bias because I am currently a supplier quality intern at a me...

I would respectfully disagree that only medical devices have been proven to improve human health, and not pharmaceuticals. In addition, a drug does not need to cure a disease in order to be classified...