This episode breaks down the core components of a successful global market access strategy for MedTech and IVD companies. We explore the importance of building a proactive regulatory roadmap, the challenges of tailoring technical dossiers for different international markets like the US, EU, and Asia, and the critical role of local representation and post-market surveillance in maintaining compliance. Learn how modern AI-driven tools can streamline submissions and help you navigate the complex web of global regulations to expand your market reach efficiently.

- What are the foundational elements of a global regulatory strategy?
- How can you leverage a single technical dossier for multiple country submissions?
- Why is an in-country representative essential for market access and maintenance?
- What are the key post-market surveillance responsibilities you cannot ignore?
- How is AI technology transforming the process of regulatory submissions?
- What are the strategic differences when targeting markets in the Americas versus the EU or Asia?
- How can you avoid common pitfalls that delay international product registration?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We combine local expertise from over 15 offices on five continents with advanced AI to manage the entire product lifecycle. From initial market research and regulatory strategy to technical dossier submission and post-market surveillance, our integrated approach allows for a single process to access over 30 markets. We act as your local representative, ensuring continuous compliance. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.