Activity

  • When we met with Dr. Simon in person for the introductory class a portion of the time we spoke about Europe’s new regulatory system, and how it has dethroned the FDA as the “big dog.” My question is, do you think that the medical community as a whole is moving towards globalization of regulatory procedures? If so, will this be beneficial or detrimental to medical device approval? I personally believe that although global regulation would lead to better and safer medical devices, globalization might add years of valuable time to the approval process. Additionally, not every nation has the same resources to equally test a product. Like anything else globalization will have its cons, but personally I see more pros to this.