The term "medical devices" is usually used very broadly when referring to a type of technology that helps patients with their health. There are challenges with the categorization of medical devices that might impact their approval process and their availability on the market for patients and providers to use. A slower and more diligent approval process might delay the population's access to lifesaving and life-sustaining technologies. A quicker and more streamlined approval process might increase the risks associated with medical technology use. Residents of the United States (US) often rely on agencies such as the FDA to offer its stamp of approval for medical devices for such devices to be considered safe and secure. Yet, medical device recalls still happen in the US, which indicates possible inefficiencies within the FDA's regulatory processes. Could inefficiencies in the FDA's medical device approval and regulation processes be causing harm and/or preventing positive outcomes by imposing high barriers to entry for medical device approval? To address this question, this blogpost uses a comparative approach to review the US and the European Union (EU) medical device approval and regulation processes using the case study of the Medrtonic's pacemaker devices. Most pacemakers are made in Europe and sold in the US. These devices not only have to pass the EU's medical device regulations but also must pass the FDA's regulations. This blog post focuses on the premarket and post-market regulatory processes for Medrtonic's pacemaker devices.