Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

@jafar When I thought about this question I immediately thought about the difference in drug regulation between the US and India. The US is known for having one of the most organized and regulated drugs governing bodies while India is…   Read more»

Posted by: @sahitya-sadineni Part of FDA’s mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are “advancing the public health…   Read more»

Posted by: @sahitya-sadineni Part of FDA’s mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are “advancing the public health…   Read more»

On average there are around 50 to more recalls in a year within the medical device industry. I have heard about the Abbott cardiac pacemakers recall. There were over 400,000 devices created and sold. The device had issues with exposed…   Read more»

Other countries including India, have certain drugs that are not banned. There drug laws and policies are different compared to the United States. Within the United States the safety and effectiveness of drugs is taken very seriously. They ensure that…   Read more»

I agree  with the initial statement made regarding this topic. I believe that all medical devices should be assessed at there own merit, especially due to advances in technology. However, I do believe when medical devices are being developed, they…   Read more»

Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

Just now in another thread a young lady asked “How do you track when a project began to fail?” Now I may not have gotten the wording completely right but you get the picture.  My response to her was to…   Read more»

@eowinomsm-edu Greetings Liz, I completely agree with your definition of what a project failure is considered to be.  I think further if the project does get done but grossly behind schedule it failed. AND if the project has to be…   Read more»

Posted by: @christoph To a layman, a surperficial assessment of 510K process is that it is nonsensical.WHY are devices being compared to devices created 40 years ago.This makes no sense to me. Why arent the just assessed on their own…   Read more»

Posted by: @amd29 In the field we will be dealing with people of different backgrounds, accents, looks and drives. What do these human differences mean to you as it relates to your function in directing their operation in the creation…   Read more»

Posted by: @dipanpatel Ethics and Quality are very related; moral attitudes and conscious awareness of standards and guidelines have to be separate from intellectual/company’s agenda. As NJIT student studying ethics and/or professionals in the industry, have you come across ethical…   Read more»

I do not think the FD ai s being too strict in their regulations. Their goal is to keep the general public safe from any harm from drugs, medical devices, and food. If they weren’t as strict as they are,…   Read more»

Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

Posted by: @mduru As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have…   Read more»

Posted by: @mem42 I haven’t witnessed anything exceptional, but in my other classes, we had a lecture about ethics and we discussed about different situations. As for my personal experience, I think that when you work in the industry you…   Read more»

Quality management is a vital part of businesses, especially those that deliver products that could affect an individual’s health like those that come from the biotechnology industry. Medical devices and drug components all rely on the nature of QA and…   Read more»