I cannot speak in terms of me finding a job position as a consultant after graduation but if I were a client or any other departments' employee that would directly receive the consult, I would not pre...

First off, as the name of the NDA says, I would suggest to make sure that you are clear of what must be kept confidential. If there is any case you can think of but not sure how to handle that accordi...

I think it is important that there is presence of a neutral third party that witness the verbal contract. I think with the technology and how we use it nowadays, it is a good practice to record the me...

I would prefer the matrix structure given that it blends the strengths of both functional and project-based setups. It allows team members to benefit from specialized expertise within functional depar...

Medical device companies can adopt several organizational development strategies to align with the growing demand for value-based healthcare. One idea is that they can invest in data analytics and dig...

Interesting question. Let's put it this way: the advantage is decision made by only one person, the disadvantage is decisions made by only that person. Why is it kept the way it is until now? It's pro...

I do not think this is necessary to be discuss: would anyone want a product without any precautions or want it when they know the product is not tested for any risk? Or let's talk about a drug: would ...

I think I can tell one situation from my personal experience. It was during COVID time and my undergraduate research work involves with studying the virus. The vaccine was not vastly applied at such t...

First off, I totally agree with someone above that it would be better to have subscription mechanism for citing all these regulations. Honestly, I think that these organization should be supported by ...

I would think of it as a multifunctional device. Usually, you would not expect a vacuum robot that is small and can also mop the floor to be as good in vaccuming the floor like a simple vacuum cleaner...

To me, insufficient design control basically means that you are not foreseeing enough problems that can incur during the development of the product. That basically means that you do not have enough "t...

To my experience, meeting minutes are ver very important. They are brief but has important information in them. We can track how the project progress through the minute and is a great resource to keep...

Design control is indeed a big help to mitigate risks in medical device development. It is basically the framework of standards and tests required for the development of such project to ensure it meet...

I do not think of it as input-output relationship, especially for design purpose. Therefore, I don't think we need an output in this case. For design control, I think of input as standard and bullet p...

For trial periods, drugs are conducted in four phases (I,II,II and IV). The first three trials test for safety, effectiveness, dosage, and side effects, which are carried out so that the drug can be a...