I also didn’t think it would be difficult. There had to be some type of lab notebook or documentation process for the development part and for testing just pull the materials from manufacturing and go from there. I think the problem would be if it fails safety testing how can the company come back and fix it.

Hello, I also agree with you that quality is the most important. The whole project ( roles/responsibilities, gant chart) is based on this product and if the product doesn’t work well everything will get delayed or worst people will fired. It is important to make sure there are checks along the way to ensure the products functionality.