Los Angeles, CA – Bridging Consulting is thrilled to announce the release of Episode 3 of the podcast series, "Alexis and Ethan Explain It All," which provides an in-depth analysis of the European Commission's Gradual Roll-Out of EUDAMED Q&A document. This episode offers a step-by-step breakdown of the critical elements shaping the EUDAMED system under EU MDR.
Episode 3 Highlights:
Alexis Carter and Ethan Gray introduce the three EUDAMED modules currently available for voluntary use:
The Actor Module
The UDI/Device Module
The Notified Body and Certificate Module
Alexis and Ethan also cover the upcoming EUDAMED modules, diving into their functions and compliance implications:
The Post-Market Vigilance Module
The Market Surveillance Module
The Clinical Investigation and Performance Studies Module
Finally, Alexis and Ethan tackle the pivotal question: “What does EUDAMED mean for the future of medical device regulation beyond EU MDR?” They share unique perspectives on how EUDAMED could shape global regulatory landscapes and influence compliance strategies worldwide.
📖 Access the full Q&A document here.
🎧 Listen now to Episode 3 and stay informed about this foundational element of EU MDR!
“This episode reflects our commitment to making complex regulatory topics approachable and actionable for industry professionals,” said Yu Zhao, founder of Bridging Consulting. “We are excited to provide our listeners with timely insights into EUDAMED’s implementation and its implications for medical device compliance.”
Stay tuned for more episodes of "Alexis and Ethan Explain It All" as we continue to explore critical regulatory trends and their impact on global healthcare innovation.
Comments