It may seem restricted, however, I would like to offer a different perspective towards these restrictions. Let's say there are two companies who are fighting for one physician to consult with. Company...

Like all legal documentation that binds you to a legal contract. It is extremely important for you to read through the whole documentation and you 100 percent agree and understand all there is written...

Both verbal and written consent or agreement has legal standing. However, verbal consenting requires a lot more effort to record and preserve. A written agreement both parties sings the original docum...

I believe I would have the skill set to excel in both roles however I think I will enjoy it more if I work as upper management. And since there are numerous studies where if you do what you like your ...

There is no perfect organization type which will be the gold standard. In addition, there is a lot of factors that can affect efficiency as well. Therefore it is important you discuss the method that ...

It is important to first have a great project leader with lots of experience with managing people. I strongly believe that one of the main jobs of the project leader is to manage team members and also...

Like in the lecture the risk management process should be designed in a way where it starts at the very beginning of the project to the end of when the product's life ends. Especially for medical prod...

I am currently working in a university setting rather than an industry setting. Therefore, we will have a different approach however the main fundamental idea is the same. For lab settings, we do a mo...

I believe it is important to have each department send a representative to the meeting. That way when brainstorming and finding risk it will be a lot more efficient and effective. That way the projec...

I would like to point out a crucial point. The manufacturing process or the design transfer success rate will depend on how well the outsourcing manufacturing factory understands the steps before the ...

Since a lot of ppl touched on the FDA portion of the question, I will try to help you understand the other portion of your question. In theory, there are unlimited ways to test if the product is safe ...

Well, the possibilities are endless. Even with a well thought out design control documents, there are possibilities of things going wrong due to us being human beings and not able to predict all the p...

I believe design control should be implemented in every step of the process from start to end of the product's life. It is important to numerically or for some cases observationally be able to determi...

I believe some way to record what has been discussed in meetings are extremely important in terms of team success and organizations. It does not necessarily have to be in minutes. However, it is one m...

For any new device, it should be good practice to always have a way to test and minimize errors or risks before the product is sold to customers. It is extremely important to do this before and well. ...