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&...

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 prac...

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...

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 si...

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. Ther...

During lecture, Dr. Simon explained that clinical trials are classified as significant risk or non-significant risk. The level of risk is determined by how much harm the subject could acquire from the...

In the lecture, Dr Simon talked about two types of quality audits, the major audit performed by an outside agency, it could be the FDA or ISO and the internal audit performed by the company itself. Th...

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 ...

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 tec...

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 ...

In the lecture Dr. Simon explained that there are three basic principles: - System Approach to Management - Process Approach - Factual Approach He also explained that when you have a quality managemen...

No GMP will certainly result in a cheaper process and the product will also sell at a lower price. Nevertheless, GMPs is what establish your credibility to other organizations, to your customers. It ...

Product failure can be described in two categories; product risk & business risk. Product failure is not a fun thing to deal with and a lot of companies deal with it in different ways. Some compan...

Interpersonal skills and business skills vary from one company to another specially in medical device fields where it's not so easy to do everything yourself with all the ISO & FDA regulations. I'...

In my opinion, there is really no scrap of a project due to patent issues or money. There is always a priority change in which project management plays a huge role depending on the business needs. I'...