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 Indonesian Regulatory Landscape: An Interview with Hussein Haidar
April 3, 2026
In this episode of The Elendi Files, Hussein Haidar, CEO of Product Registration Indonesia, breaks down the 'obligatory favoritism' of local content (TKDN), the risks of exclusive distributorship, and the evolving Halal requirements for medical devices.
Navigating the India Regulatory Landscape: An Interview with Nayeem Syed of Infill Life
March 27, 2026
Teddy, General Manager of ElendiLabs, speaks with Nayeem Syed from Infill Life about the complexities of entering the Indian medical product market, CDSCO regulations, the Sugam portal, and recent updates.
Navigating the Mexican Regulatory Landscape: An Interview with R. Yoloxóchitl Macias Ortega of Anglex Consultores
March 21, 2026
R. Yoloxóchitl Macias Ortega discusses the intricacies of COFEPRIS, the digitalization of Mexican health registrations, and strategies for medical device manufacturers to enter the Latin American market efficiently.
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.
Stay Ahead of Regulatory Changes
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