Looking at the lecture, I can see that Quality Assurance builds the methods, rules, acceptance criteria, and systems that prevent errors in medical device development. On the other hand, Quality Contr...

In Dr. Simon’s lecture, he clearly linked the quality system hierarchy back to management. Quality starts at the top, where management defines the mission statement, leading to the quality policy. Thi...

I agree with everyone's response regarding the need for engineers to understand the regulatory basics in order to create products that don't need revision early on in the design process, since they ca...

EUDAMED is a big step towards transparency with medical devices. Even after a year from the last post in this forum, EUDAMED is still not fully operational or mandatory. It was originally set to becom...

@jacobchabuel I think you give great points regarding safety and how the public would view a device if it were not tested beforehand. To answer your question, I think the FDA should create a program t...

I think pushing forward with development is crucial for any kind of research and innovation. However, a balance between safety and innovation must be found. Pre-clinical research exists for a reason, ...

@danieshat1 I think the profession of a physician can combine both academia and industry research. A doctor can conduct research and clinical trials for different medical devices if they partner with ...

I agree with how difficult the organizational and approval process is extremely time-consuming since, as stated in the lectures, lawyers take months to sign contracts, and things don't always go as pl...

@vthampi Hi vthampi, I agree with your points regarding the ambiguity of academia and how many tasks may take much longer than expected. With academia, usually Murphy's Law applies, and the results th...

I agree that having a timeline is crucial to managing multiple projects; however, something that the previous two responses mentioned but did not expand on is the importance of communication in managi...

Most of the replies in this thread are from 2023, and I find it very interesting to see the thought processes of these times. I agree with what previous replies have said, where humans need to use AI ...

If you are pursuing a Master’s in BME, then you are most likely intending to use the knowledge gained from your classes in industry or in a practical setting. In this case, the ratio of practical to a...

The reason I pursued a BME degree was that it blended my love for engineering and biological science. I want to be a physician in the future, and I feel that having a comprehensive knowledge set befor...

I don't think AI will be able to completely control the medical industry, since every major technological advance has historically created new opportunities for human involvement rather than eliminati...

@ag2357 Hi, I feel the same way about academic research as well. I have joined many labs to hopefully get my name on publications, but a lot of the work I do is usually for grant writing. Even though ...