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For companies that want to move their management systems to the next level or that want to sell internationally, ISO 13485 is the international standard that may be required. Most countries will require this certification. In this webinar, Darren Reeves, president of DP Distribution & Consulting, will discuss what ISO 13485 is and how to get certified. Topics include: What is ISO 13485? What is the process? What is a notified body? What are the main sections of the standard?…Find out more »
MNC Network Webinar Series #9: I want to sell my medical device outside of the US. What do I need to know?
You made it through the pandemic. You followed the appropriate U.S. regulatory pathway and achieved any required marketing approvals. You have successfully grown your customer base and are now ready to expand into other markets. How do you do that? In this webinar, Darren Reeves, president of DP Distribution & Consulting, will discuss different countries have different rules. What quality system is required? Topics include: Focus on E.U What is the MDD/MDR? What is a CE mark? What are the…Find out more »