Launching a medical device in multiple markets poses significant challenges. In this article, we examine the key disparities between the US and EU markets, as well as the considerations involved in pursuing a launch in both regions. While manufacturers in the EU must obtain a CE mark in adherence to the EU Medical Device Regulation (MDR 745/2017), the US mandates clearance or approval from the FDA. Compliance with Quality Management System standards is imperative in both markets. Regulatory controls and marketing pathways in the FDA and EU are risk-based. The reimbursement processes for medical devices differ between the US and EU markets. In the US, reimbursement involves either the Centers for Medicare & Medicaid Services (CMS) or private insurers. On the other hand, in the EU, reimbursement is determined by national healthcare systems or private insurers. Language requirements also vary between the US and the EU, with English being the preferred language in the US, while the EU requires compliance with the local languages of the target countries.