Based on the organizations discussed by Simon. I would choose to have a functional organization. It would allow me to have departments with people familiar with each project that is needed. This would...

I believe that the best organizational structure is functional and project-based. These two are strong because you can place people in groups/teams based on their specialty. This allows for optimal wo...

I currently work in a functional organization. A group of scribes is selected to work on specific doctors only and we work together to complete all the charts necessary while other groups have other c...

Medical device startups and manufacturers should take the PMS process as a holistic approach to maximize the gains including fewer medical device defects, improved user safety, and, in certain cases, ...

When dealing with risks for medical devices, there is always going to be an instance where risk is accepted. Any device has to accept some risks when a device is released for use. But you always want ...

Yes, I believe that risk management is an important part of the planning phase, essentially it is very important in the whole aspect of making medical devices. Risk management is critical in avoiding ...

I think meeting minutes are very underrated. They are taken for granted and passed over quite often. Meeting minutes can be crucial to you if you happened to zone out or take your attention off of the...

I believe the most important part of design control is the design verification phase. I chose this part of the process because the verification of the design is crucial to being a "good" product in my...

Regulation of medical devices is different across the world. Some places have very complex requirements while others have none at all. In the U.S., we have established Design Controls. Design controls...

I believe that double-blind studies are beneficial. This is due to the fact that a researcher or overseer of the patient could have an impact on the patient if they know what is given. If the research...

I feel that this law is very beneficial to those that are terminal and/or looking for the last hope to find a way to stop the progression of their disease. Making this a law is allowing people more ho...

I think they are lots of risks and benefits when it comes to human clinical trials. Some of the most noticeable advantages are that it helps further research, a new drug could do less harm to the side...

I think that it is very important for a salesperson to be knowledgeable in whatever aspect it is that they sell. Someone in sales for medical devices should definitely be well versed in some of the wa...

You are currently developing a company to manufacturer dental tools. Who are you planning to sale to? (Physician, Hospital, Retailer) Explain your answer. If I was to start a company that manufactur...

When i think of a companies that are corporations, I never think of that corporation being specifically an "S-Corp" or a "C-Corp". I just think of them as a corporation, can you please provide an exam...