Good discussion topic. I found this interesting link that provides a helpful visual on page 3 to understand where Phase I Clinical Studies would occur. As per the source, it shows that as part of the ...

The benefits to outsourcing the design transfer into manufacturing process are leveraging multidisciplinary expertise have breakthrough ideas from other industries and technologies and be able to expa...

In general, validation is an important part of getting a product to market because it verifies that the user needs are met. Even though it may take up to a few years to complete, it can improve the la...

I agree with the responses so far. One of the aspects that I think design controls help to bring out in the product development process is risk management. This is a way to take the policies, procedur...

I agree with what has been said so far. The design input is the document that provides the basic requirements of the product. It takes the input from different sources like marketing, sales, direct te...

Fady, That is an interesting point to bring up. With combination products, if I understand correctly, the company must identify first the necessary center for the primary use of the product. Once it ...