Activity

  • jl959 replied to the topic Design Control Process in the forum Introduction to Project Management 6 years, 2 months ago

    While I have yet to work in industry, I am most interested in the initial product design/planning phase that includes determining spec and coming up with a new design that combats the problems of existing products. However, I think I would need to have experience working in the verification stage first, in order to fully understand what it takes for the FDA to approve the final product for clinical testing and eventually release to the public. This will hopefully prevent my team and I from setting unrealistic goals from the very beginning of the design process, which can push completion past the deadline. It can even lead us to dropping the project completely due to underestimating FDA requirements and amount of time needed for approval.