That is true, it can be pretty expensive and not financially efficient for a clinical trial company to have to pay each participant subject for partaking in the study. Other than money, another qualifying incentive that could possibly attract potential…   Read more»

I believe that would depend on if the company is working on something with high demand and urgency. For instance, I work for a laboratory that has a pcr lab that processes covid19 samples. With the height of the pandemic…   Read more»

With Design Control, I believe that Output is the most important part. The output is considered as any work that’s produced at the end of the design. That would include any drawings, manufacturing instruction, or material specifications. The output is…   Read more»

@mattie718 I would have to agree with you in the sense that the Design Input Document (DID) and Design Specification Document (DSD) are similar documents. But I do think that the DID is most vital because the writer who composed…   Read more»

@cem34 I’d have to disagree with you. I believe that validation is incredibly necessary for a medical device. I could say that I work in the industry because I work with instruments that are use to screen for drug enzymes….   Read more»

@anthonynjit This is true. Developing protocols based on tensile strength of a device after repeated use is a commonly overlooked factor. I would have to believe its because big corporations might sign a contract with the buyer and cover the…   Read more»

An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because…   Read more»

An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because…   Read more»

Patients usually don’t even realize that they accept the risks that are associated with the medical device. Although the risk management process can be tedious, it is very essential for making sure a device functions as per its intent to…   Read more»

Apparently it changed from “as low as reasonably practicable” to “as far as possible” Basically the first one, ALARP; allows a manufacturer to include economic impacts into considerations as to what are acceptable and unacceptable risks. AFAP; does not allow…   Read more»

  I feel like its better to work with people who are more knowledgeable in their department role. Working on a project team with people who already have a pre-existing relationship with can get dicey. There would be interdepartmental struggles…   Read more»

@cassiem I totally agree with you on the fact that the team would be most effective when made up with different types of people. When you involve different types of people on the team with different professional backgrounds and a…   Read more»

@cassiem I totally agree with you on the fact that the team would be most effective when made up with different types of people. When you involve different types of people on the team with different professional backgrounds and a…   Read more»

I also believe I can excel in both areas; Upper management and middle management. I might prefer being in a position of upper management because I find myself to be quite strategic and pretty good at visualizing things in a…   Read more»

That is true, it can be pretty expensive and not financially efficient for a clinical trial company to have to pay each participant subject for partaking in the study. Other than money, another qualifying incentive that could possibly attract potential…   Read more»

I believe that the majority of the reason for why clinical testing/trials are done for pharmaceutical drugs is to document any potential or inherent side effects that may transpire when taking the drug. If there is documentation of a person…   Read more»

Placebo controlled trials are ethical from a bigger picture sense. There is a greater good at hand when conducting them. It is for a good and moral purpose, so therefore, it should not be considered unethical. They are necessary for…   Read more»

Yes it does seem like the cons overweigh the pros when referencing C-Corp vs. S-Corp. However there are many cases where C-Corp is the best option. For instance, C-Corp is better for international owners because C-Corp does not require the…   Read more»

Hi Cassie, you are right. Technically a sole proprietorship isn’t a corporation. First of all, a corporation is multiple people. Also, a whole corporation cannot go to jail per say, however, a sole proprietor surely can. I believe the reason…   Read more»

Great question, Cruz. I think a lot of the business scheme in the engineering world is lost when working as a field tech or most entry level positions. I doubt they have to be concerned with the opinions of shareholders…   Read more»