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...

The benefits to outsourcing the design transfer into manufacturing process are leveraging multidisciplinary expertise have breakthrough ideas from oth...

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...

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 manage...

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 ...

Fady, That is an interesting point to bring up. With combination products, if I understand correctly, the company must identify first the necessary ...