A few possible solutions if it were ideal situations. First, there should be a regulatory affairs individual from the company that is assisting or consulting with 30%- 50% of the project. This allows for technical input of what regulatory organization should be used for the medical device. Then this individual asks regulatory affairs at the FDA which organization it falls under. Then write the required documentation. In terms of global regulations, a meeting should be proposed to write a generic form for medical devices that can be universal. Also, the materials being used should be allowed for everyone to use if we are indeed working together to make the quality of life better.