I believe that the purpose of the FDA is to ensure that the product that is being sold will not cause any adverse reactions or cause more harm than good. When determining the quality in terms of how w...

One of the few jobs that are fairly easy to attain is the position of a QC analyst, the person who performs QC functions and conducting testing on machinery that is laid out by the QA department. The ...

In my workspace, I have had to do a very small amount of QC and QA in the form of executing IOQ, PQ, and OQs for the validation of machinery. Being on the executing side of the side, the biggest facto...

I see the point you are making that often times FDA approval comes with a briefcases of exceptions and side effects which ultimately make the drug look like there is one problem that they are fixing b...

I believe the fact that the procedure and ultimate rigor and length of time that is used in getting an FDA approval is ultimately for the best for safety consideration. A medical device is such a prod...

The addition of 510(k) procedure has been a topic of debate for the longest time. From an industry perspective, it is very much vital that a company can use such track to get their product on the Mark...

Industry research is quite different from academia research in that in industry the end goal often has a higher probability of success because the purpose of it was to fix something or to make a proce...

I believe cutting corners in any regulated research field should strictly be prohibited and avoided at all costs. A perfect example of this would be the covid vaccine that was released by Pfizer, Mode...

I believe the consequences of abandoning a project has vast different consequences when it comes to industry and when It comes to academia. I believe that in industry money speaks for all. Everything ...

The biggest lifeline of a project is its access to money and keeping track of expenses wherever necessary is a big task to make sure the project is well funded and unforeseen circumstances are taken i...

Scope Creep in my opinion is most definitely an ongoing problem as a project is shifted from the initializing process to the planning and executing process. Often times I believe while actually execut...

I too agree with the points made above to consult another project or one that is similar to the project at hand and see how long the project took. Being in the industry I have seen on many accounts pr...

With the increasing integration of computers to our daily lives as well as into the medical device and biomedical engineering discipline, should it be required from students in BME to take advanced co...

Due to the COVID-19 pandemic the onboarding of a virtual setting for many jobs has permanently changed the way many companies have been now operating. I believe the addition of hybrid model of work ha...

Some of the issues that biomedical engineers are facing especially now is the fact there is such a large variety and vast quantity of applications that can be used in the field. Biomedical engineers a...