Last seen: May 7, 2020
It is an absolute necessity to improve the relationship of QC with other company departments. It is in fact in those other departments best interest t...
I don't believe companies intentionally want to fail to adhere to the rules. With the analogy of the speed ticket, for instance, let say you are rushi...
When the De Novo process was first initiated, sponsors needed to submit the premarket notification (510(k)), to which the FDA would issue final 510(...
An example of FDA approved wireless medical devices is the wireless electrocardiogram. It consists of the ECG monitoring circuit, microcontroller cir...
Combination product: metered dose inhalers, MDIs An MDI is made up of a pressurized canister containing a drug substance and possibly excipients form...
While I find it interesting that the standard for labeling is inverted between Sweeden and the US, I am not a bit surprised that the US opted to have ...
Although I believe animal testing is clearly unethical, I do find the efficacy of their results extremely valuable. Animal testing has been the most a...
As others students stated, referencing the Toxicity Table from ISO 10993 should give a general idea of tests needed prior to clinical trial phase. Ul...
Research is always important no matter if it is in Industry or Academia. As Dr. Simon mentioned research in Industry is usually to create a solution...
Before considering if Industry research is " successful" , we need to define what " success" actually is. What parameters are we using to measure suc...
I think all these three features of a project are all intertwined. Although the achievable seems to stand as the most important one, in reality, it wi...
Besides having a solid technical background that most people are suggesting, I believe a manager should have excellent communication and people skills...
I think no single phase is more important the others because the end project results in the efficiency of all the phase combined. However, I think the...
One project in which I encountered crucial setbacks was my capstone project assigned to a group of five. We had a year to submit and present our findi...
I strongly believe that, prior to execution of any projects, several rounds of planning and review of milestone should be conducted. The project manag...