I think Quality department cannot be treated as a stand-alone entity in the company ensuring quality at every stage of product development. As the quality department ensures quality in every other dep...

I think new technology that has huge potential should not be delayed in reaching to the people who really need it. But once the product reaches them, its stability, durability and reliability take cen...

The main purpose of an audit or inspection is to check if the regulatory standards are being followed in the way and magnitude that they need to be followed by the company. While I was working as a qu...

The report by the institute of medicine talks about how the 510k process has become burdensome and time-consuming and addressed the inadequacies of post market regulations of medical devices by the F...

Blood glucose monitor can be considered a combination product as the sensor/ test strips that detect the blood glucose and the software that computes the calculation of these glucose levels are two di...

Blood glucose monitor can be considered a combination product as the sensor/ test strips that detect the blood glucose and the software that computes the calculation of these glucose levels are two di...

I don't think e-cigarettes should be classified as a Class III medical or drug delivery device. From this week's module, in order for a device to be considered as a medical device, the manufacturer fi...

In a university setting, a university sets aside funds for an entire year for all the projects going on in the university irrespective of the type of financial need each department has in terms of res...

There are various types of biocompatibility tests depending on the type of therapy the material is involved in delivering. One of the most important is cytotoxicity test that goes hand-in-hand with he...

I was part of clinical research where I was working on the quality control of medical images from the beginning of the trial to the end of the study. Most of the trials are carefully planned and execu...

While working in a team, it is usually expected that every person in the team contributes equally efficiently to all the tasks assigned to the team. This way of project management would be ideal when ...

From my experience working in clinical trials projects, assigning multiple project managers for a single project depends on the size of the project, the areas of expertise that each project manager ha...

After working in the industry for two years, I can say two points: companies either want a highly skilled professional in one area or someone with a variety of skills who is versatile and can adapt to...

I think the differences between working in an academic setting and working in an industry can be compared in two ways: a. efficiency and productivity and b.creativity-and-time-limitation. While workin...

I think there needs to be a right balance of practical and informational courses in the curriculum. In any field, the requirement for informational courses would out-weigh the number of practical cour...