This was such an awesome course! Taking this class parallel to my internship really helped. It helped me understand more about my company (and other medical device companies), its structure, and depar...

To be honest, I think these laws are necessary and I don't really think they are too restricted. Yes it does make situations awkward (like when the doctor brings his wife and her meal can't be payed f...

I think we need to first understand that both verbal and written agreements are recorded in some manner or the other. So both can be used and defended with. The difference is that verbal agreement usu...

Building a strong team is crucial to working better. I believe that a strong team is made of people with a mixture of skills. For example, they must have certain knowledge in their field, must be moti...

For collaboration process, I think matrix type organization is the best option. A matrix type organization allows people to move around based on projects and their talents. I think this is a good opti...

I work in a functional based organization. I work for a specific department and my manager is the department supervisor. I haven't been a part of a project, but I work on tasks that is required within...

When it comes to Off-The-Shelf (OTS) products, I think the quality department knows that consumers don't really read the labels and instructions that warn them about risks, and try their best to make ...

This is a great question! For high level risks, I would try my best to go with avoidance, I do not want to put the patient and the company at risk, given that we know the failure occurs frequently and...

Although severity and number of occurrence are the main large categories that must be looked at for risk management, there should be more evaluation and discussion of other categories such as user's a...

In the company that I work for, we interchange the term "Design Control" and "Document Control" because everything in design control is detained in documents called Standard Operating Procedures (SOPs...

As many of the students stated, design inputs so usually come from research and other investigational ideas. I would like to add that some also come from doctors and other medical companies. Hospitals...

I think the need or the advantage of the DID and DSD is that they serve two different audience. DID, which contains the broad specifications, is great for the customers, the ones who are actually inte...

From my experience in research, we did also document a lot and were very specific. But we didn't have anyone inspecting us or our documents, we did it for the sake of honest data that was needed for p...

When I used to work at a research lab on campus, I didn't really pay much attention to the meeting minutes sent to me. This is because it had the information (tasks and decisions) for all the members ...

Informed consent in very very important and I'm happy to say that now a days, it is taken very seriously. Back in Henrietta's case, I don't even think she was given a consent form, she just went for c...