What general FDA compliance steps must a [company removed] take to sell a medical device in the US?

We can provide you with a structured, high-level view of FDA requirements tailored to medical devices, and guide you on whether local representation and ongoing legal support are necessary for inspections or enforcement actions. As an international firm, we are equipped to coordinate across jurisdictions and ensure that your expansion into the U.S. market is both compliant and strategically sound. We would be glad to arrange a Zoom meeting to walk you through the regulatory framework and outline how Bourgg can support your entry into the U.S. medical device sector.