I do agree with the above posts up to a certain extent. Yes the testing portion of any trial can be very time consuming and daunting but accomplishing your goals is the most rewarding. Ideally in a R&D facility, engineers draft the protocols and plans and most of the time test technicians are the ones that execute the tests which really takes a…[Read more]

I agree with the comments above. These simulations helped me understand how engineers have to solve issues on a daily basis. From simulation 1 to simulation 3, I had the opportunity of putting in practice every lecture learned throughout the semester and work with different classmates whose different skills made me realize that working in teams is…[Read more]

I think the combination of the course options we have is sufficient since we get a taste of statistical analysis, CAD design, Coding (Labview/Matlab), & medical device development. With this being said, we get a opportunity to take two classes outside the biomedical engineering department such as mechanical, industrial, pharmaceutical engineering.…[Read more]

I do think that maintaining the budget of a clinical study could lead organizations to conduct the studies in developing countries to save on costs. Balancing funding with results might not be easy since it could be difficult to plan a clinical protocol that will for sure produce a significant evidence without going over budget. By conducting…[Read more]

I have not had any experience yet on clinical studies but I would like to develop a little more on blinded clinical studies. In this type of study, subjects are blind to which treatment is given. There are three types of blind clinical studies,
1) Single Blind- The subject, but not the observer, does not know which of the possible treatments he is…[Read more]

Corrective and preventive action (CAPA) can be viewed differently by employees within pharmaceuticals and medical device companies. Some see CAPAs as simply an onerous task given to them to complete in order to “stay compliant,” while others look at CAPAs as simply a number based metric that needs to be reduced. However, the best view of CAP…[Read more]

Recently at work, we faced that most real time products coming out of the chamber were dictated as non-conforming upon pressure decay testing. At first, R&D engineers thought that probably the technician was not performing the test as specified in the test instruction. Nevertheless, after trying the test by themselves, they found out that the…[Read more]

GMP’s ambiguity does make it more difficult for startup companies. These companies could have the required description in order to have a compliant quality system but they do not have an pre-existing framework that they could follow. Therefore, creating quality document, SOP’s could be challenging, since the terms used in these documents needs to…[Read more]