De Novo is a classification process which uses a risk based strategy for new novel devices whose types has not previously been classified. It can be used for devices that would have been classified into Class III to allow them to be classified into Class I or II. For the De Novo process an application must be sent to the FDA, and if it is granted…[Read more]

A product that was recently recalled was the BD Intelliport Medication and Management System Sensor, which was officially recalled by the FDA on January 09, 2017. This product was recalled on its inability to assure sterility of the product, which poses an increased risk of infection to the end user.
For this type of recall (product sterility), I…[Read more]

Based on the research I was able to find the FDA does regulate all cigarettes, smokeless (e-cigs), and roll your own tobacco and these regulations have been in effect since 2009. On August 8th, 201 the FDA finalized a rule to regulate ALL tobacco products.
In my opinion I do not think there is a difference between cigarettes and e-cigs in terms of…[Read more]

In my experience in working as an R&D product development engineer in the medical device industry, I would say that projects do generally get pushed to get done quicker due to project deadlines but I do not feel that it generally impacts the success of the product. When working in the medical device industry project deadlines are often driven by…[Read more]

As many have already said in this thread, both types of research are important and I do not necessarily see one as more important than the other. There will always be a need to solve current societal problems, for this reason research is needed to help further understand these problems so that a solution can be identified. Broader types of…[Read more]

In my opinion, most of the challenge for project management of medical devices comes from the process (aka Design Controls). Developing medical devices requires a lot of detailed traceable documentation that must been done in a certain way. All of the hundreds / thousands of documents that are generated as a result of the development of medical…[Read more]

I have experience working in the industry and my company uses Microsoft Project. Based on my past experiences, and in talking with others who work for my company, Microsoft Project is definitely one of the most popular softwares that is used in any industry where project management is needed (which is practically every industry). Microsoft…[Read more]

Another piece of advice I would give to current engineering students would be to potential work in the industry for a few years before going back to get your master’s degree. This is an approach I have taken with my education, and I feel like I am benefiting from it. Working in the industry for a few years allows you to start to understand what i…[Read more]

My answer would be it depends, and my answer stems from what you want to do with your career as an engineer. I believe that some engineering jobs require more technical (academic) knowledge, and for those types of jobs it is easier to learn the ins/outs of working in the industrial environment on the job. Other engineering jobs that are not very…[Read more]

I agree with the other two posts, definitely try to get into as many co-ops / internships as you can while your still in school. I have been working in the industry for about 6 years and I did not take advantage of any co-ops or internships while I was a student. Now that I am working I get the opportunity to work with the interns / co-ops that…[Read more]

My answer would be it depends, and my answer stems from what you want to do with your career as an engineer. I believe that some engineering jobs require more technical (academic) knowledge, and for those types of jobs it is easier to learn the ins/outs of working in the industrial environment on the job. Other engineering jobs that are not very…[Read more]