We live in a world where technology is fluid, which makes knowing what is legally required for your product from a regulatory stand point, challenging to say the least. Even when you are a huge company with years of experience behind you and a dedicated regulatory team- things change., quickly. In this talk, we will take a high level overview on the world or Regulatory, examine 4 case studies for scope, time and cost, how to prepare, and give some useful tips and tricks.