I agree with the notion that an organizational structure leads to certain cultures within the work place that may make or break a potential project. In a functional organization, each department is di...

I feel as though each organizational structure has its own strengths and weaknesses; however, depending on the size or needs of the company one structure may be more advantageous than the others. For ...

I have never worked as part as one of these teams; however, with that being said, I am torn between wanting to work with either a project-based organization or matrix organization. In project-based or...

I feel as though all the mistakes you mentioned highlights the fault in companies when it comes to understanding how to handle risk management. I agree that risk management and design control are sepa...

The major ISO regulation governing Risk Management for medical device companies is ISO14971. According to the link, the major requirements for a medical device company has to follow is to construct a ...

In Capstone, we had to formulate test plans in order verify our design. Should one of our tests fail, we were taught to reassess our design and change the specifications and tolerance in our document ...

I personally don't have any experience in industry; however, we've had design reviews for our capstone project at NJIT. The way these meetings go is that each team has their requirement documents or t...

It is true that the engineer is supposed to "make up a test"; however, the test needs to reflect the section of the design requirements that the test will be verifying. In the Capstone class in NJIT, ...

Although it may hinder the product a bit in a business sense, I feel as though a medical device meant to work with humans should require validation even if it already passed the verification phase. Th...

I don't have an work experience; however, for Capstone my senior year we had to develop a project schedule that was essentially a Gantt Chart. As such, you can think of a Gantt Chart as a detailed pro...

From the deliverables Dr. Simon requested for this class I noticed a lot of similarities between them and the deliverables we had to submit for the undergraduate capstone project. In capstone, we were...

In the past, consent was not used since medical regulation was still young and not widely enforced. In the case of Henrietta Lacks, the doctor did not give her the option to use her valuable cells for...

In a single blind study, only the investigator knows what is to be used on the subject, this has its advantages since the investigator in this case has complete control over what is given; however, th...

I personally feel as though placebos are necessary for studies and clinical trials. When doing statistical analysis, you'll have a controlled-group that'll receive the drug or device in question for a...

EI can easily turn into manipulation as the sales pitch has to be tailored to certain demographics. Dr. Simon mentions in his lecture that people may not even know they want something until they heard...