MedTech Compliance 101: Your Guide to Entering Global Markets

Medical Device Global Market Access

This episode provides a foundational guide for MedTech companies looking to export their devices. We break down the essential first steps of global regulatory compliance, from understanding device classification and risk levels to implementing a robust Quality Management System (QMS) based on ISO 13485. We’ll also touch on the specific requirements of major markets like the United States (FDA) and the European Union (EU MDR). Key Questions: • What is the absolute first step before exporting a medical device? • How does a device's risk level impact its regulatory journey? • What is a Quality Management System (QMS) and why is ISO 13485 the gold standard? • What are the key differences between the US FDA and EU MDR requirements? • How did the EU MDR, effective May 2021, change the game for manufacturers? • Why is risk management (ISO 14971) a continuous process? • How can a company prepare for audits in multiple countries? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.