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1. 

   Regulatory Strategy Essentials for Digital Health: Key Takeaways from Our Webinar

   We showed how to accelerate your runway to market through actionable steps that will shave months off your route to regulatory approval.

   Dr Peter Boxall Lead Medical Writer

2. 

   Vigilance & Incident Reporting: Everything You Need to Know

   Navigating the Complexities and Ensuring Patient Safety in Medical Devices.

   Gabriela Cardoso Regulatory Medical Writer

3. 

   Achieving EU MDR approval when you are approved under FDA

   Our guide to navigating the transition from FDA approval to EU market access.

   Chandini Valiya Kizhakkeveetil Regulatory Medical Writer

4. 

   Post-Market Surveillance (PMS): Understanding PMCF & Vigilance under the EU MDR

   These serve distinct purposes and have different methodologies under the MDR framework. We breakdown each.

   Ronghe Xu Regulatory Medical Writer & Strategic BD Lead China

5. 

   Implementing Master UDI-DIs: Key Insights from MDCG 2025-7

   Grouping devices with design similarities under a common Eudamed ID could unify them under a single master UDI-DI

   Dr Will Brambley Lead Medical Writer

6. 

   In the World of Regulatory Writing: 5 Lessons Learned

   Let’s break down some key lessons learned from the writing process and share practical tips to navigate them with clarity (and your sanity) intact.

   Kamiya Crabtree Regulatory Medical Writer

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