Introduction: The journey to bring a medical device to market in the United States is a complex and highly regulated process that necessitates meticulous planning, thorough documentation, and adherence to…

Introduction: For several manufacturers of medical devices, access to international markets is crucial. As technology evolves quickly, obtaining marketing authorizations is essential, especially for new and novel devices. Gaining development…

Overview: With the initial goal of averting another European war, the European Union (EU) was established in 1993 following several treaties dating back to the 1950s. This geopolitical entity was…

Introduction: The development and distribution of medical devices play a crucial role in advancing healthcare and improving patients' lives. However, before a medical device can reach the market, it must…

Introduction: Protecting and promoting the general public's health and safety, including healthcare provision, is one of the government's fundamental duties. A functioning healthcare system requires readily available, reasonably priced, safe,…