Due to working in the industry I was familiar with the FDA requirements and regulations, but this class certainly helped in providing background and information on how the regulations for the EU works. With the EU they have 3 major directives to follow which are the Medical Device Directive, the In Vitro Device Directive, and the Active Implantable Medical Device Directive. Additionally, the MDD has classifications based on risk whereas the FDA focuses on safety and efficacy.

Hi All,

Thank you for the great question. I feel these classes have greatly benefited me as well. I work mainly in the pharmaceutical side of the industry, with very little done in medical devices. However taking these courses, I have learned much about the FDA and EU regulations. Although I had experience in the pharma industry, I have learned through this course much more of the medical device regulations and similarities that they have with the pharma industry. The main benefit I have gained from these courses is a better understanding of the difficulties that can be faced in the medical device industry to create and manufacture a medical device.

-Andrew Nashed

Hi all,
After my undergraduate, I have to say that I really did not have any background knowledge of how the industry worked in regards to medical devices. I learned a lot from part 1 and part 2 MDD. From the classification of the devices to design controls and FDA & EU regulations. The understanding of design process led me to set an area in which I really would like to work and I started searching for jobs that I could relate with. Fortunately, the understanding of design verification and FDA regulation, finally made me confident on interviews, thus leading me land my first job in the industry.

Having working in industry, this course and others taught by Dr. Simon are definitely inline with what one would experience in the industry. Definitely a valuable set of courses to take within the BME department. Knowing the process, definitely helps in the acquirement of a job as well. The company would have to spend less time and resources to get you acclimated with the procedures. I've always felt, all BME, Pharma, Biology departments should have courses on FDA regulations and protocols, for that's where most of the graduates end up being in.

Hi everyone,

When i graduate from my undergrad i was really lost on what career path i wanted to follow so i decided to do my master and maybe try to learn more and maybe figure out by than which career path i wanted to take. I decided to take Medical device part 1 since my adviser said you would learn technical experience instead of theoretical, I decided to take, and by taking part 1 and now taking part 2 it allow me to see a career path which allow me to understand really well all the process that a company has to do to take a medical device to the market, and how the FDA operate with this devices. This class also have help me to understand a lot of the jobs requirements, which now I can put it on my resume since now I know what they asking and since i read and learn the material it allow me to be a candidate to this medical device companies jobs.

For my experience, this is the fourth class I have taken with Dr. Simon and the content itself has been very helpful to relate to the industry. For instance, the two series of medical device development definitely helped me understand the process of the product design process. Also, all the training I had to go through like SOP’s and processes to learn, the base knowledge from these classes helped me get the general idea and allow me to focus on the companies more specific needs. For those who have no industry experience, these courses I think provide a nice idea of what you will end up facing sooner or later within the medical device industry and provide a good head start.

Similar to Viraj D, I'm familiar with FDA regulations from my experience in industry, but I really didn't understand EU regulations until I took this class, so I found it very interesting to learn about the differences and similarities between the US and EU medical device regulations. I am sure that I will come across EU regulations sometime in my career, because my company sells many of its devices in Europe, but I have not been involved in any of these projects yet. Overall, I think this class is going to be beneficial for my career.

Being that I am a fairly new engineer that entered the work industry, this course has helped me transition from a student to worker. After taking one of Dr.Simon’s courses my spring semester I knew that in order to get my tuition worth of masters program I needed to take all his courses. I learned so much about the design control process and project management material in other courses that he teaches. In this course, I began to understand EU and FDA regulations more in depth. It’s the perfect timing since I got involved in an international project at work. So Dr.Simon’s course helped me understand the path I needed to take to complete my projects at work. This course has been so relatable to the medical industry compared to many other courses I have taken thus far. The breakdown of IQ/OQ/PQ within the process validation/verification lecture pretty much covers 5 to 10 SOPs that most engineers have to be trained on.