I have been working as an engineer for 3 years and enjoy what I am doing. I still am not sure if I want to take a technical or managerial career path. I think I would like to gain some more technical ...

I think there is another very important aspect to this topic that I would like to bring up. I think it is important that managers recognize what type of work motivates their employees, and give them m...

The division of the company that I work for only submits 510k applications, and the FDA cost associated with submitting a 510k is $10,566. In 2016, the average time to get 510k clearance was 177 days....

Several of the posts above mentioned how that retention is important because new hires need time to get trained in their job, and I want to emphasize that this can have a huge impact on a project. New...

I agree with everyone above that I found these classes very beneficial to me, and especially the topics covered in AMDD helped me gain a better understanding of process validation. The simulations wer...

My company recently underwent a restructuring and recently formed a new clinical department. Before this we really did not focus our efforts on clinical studies, as we were releasing products via 510k...

Comparing the simulations with my experience in industry, I can say that they are very representative of what happens in industry. Often after submitting a proposed solution Dr. Simon would come back ...

I think there should be different levels of rewarding motivation, so team motivation should be rewarded separately from individual motivation. For example, teamwork is encouraged, but it makes sense t...

It is a well known fact that Americans work more hours per week on average than most other countries in the world. Do you think that Americans are putting more hours in because they are more motivated...

In my career thus far I have definitely found that challenging and interesting work created the most motivation for me, similar to the results of the poll that Dr. Simon showed in his lecture. When I ...

A CAPA really just provides a systematic way for companies to address nonconformances, fix them, and prevent them from happening again. One benefit of using a CAPA to do this rather than just doing it...

Based on my experience in industry, internal audits are conducted on a regular basis (usually once a year) by someone who works for the company. This is just a requirement that most companies have in ...

I think kak33 gave a very good explanation of an effective way to bring up this topic with management. An employee needs to take the initiative to write out exactly why they think that additional head...

I think one of the pitfalls of the WBS could be not breaking it down far enough. We learned that it is important to break down each task into subtasks and so on so that when you are completed, you hav...

I think krp67 brings up a very interesting and important topic in regards to communication techniques and style for medical device projects, and I think many projects struggle simply because of poor c...