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. I...
I feel as though each organizational structure has its own strengths and weaknesses; however, depending on the size or needs of the company one struct...
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 organi...
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 agre...
The major ISO regulation governing Risk Management for medical device companies is ISO14971. According to the link, the major requirements for a medic...
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...
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 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 ...
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 ev...
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...
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 un...
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...
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 ha...
I personally feel as though placebos are necessary for studies and clinical trials. When doing statistical analysis, you'll have a controlled-group th...
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 ...