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The US vs. the EU: A look at the pre- and post-market regulation of medical devices with Medtronic’s pacemaker devices as a case study.
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…