The Elendi Files
Your essential guide to navigating the global regulatory landscape for medical products.
Hosted by Teddy, General Manager of ElendiLabs, this podcast connects you with regulatory experts and industry leaders. New episodes cover EU MDR, FDA, market entry strategies, and more.
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Each episode features an in-depth interview with a regulatory expert. Read the full transcript on our articles page.
Navigating the EU MDR Marathon: An Interview with Andrew Gibson of AKRA TEAM
March 16, 2026
Host Teddy sits down with Andrew Gibson, Senior Managing Consultant at AKRA, to discuss the complexities, costs, timelines, and roadblocks of the European medical product regulatory landscape (EU MDR), with specific advice for startups.
What You'll Learn
Regulatory Deep Dives
Expert breakdowns of EU MDR, FDA requirements, clinical evaluations, and compliance strategies.
Global Market Entry
Practical guidance on timelines, costs, and strategies for entering 50+ regulatory markets worldwide.
Industry Expert Interviews
Candid conversations with senior consultants, notified body specialists, and regulatory leaders.
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