Podcast Episodes
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Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond
This episode explores the transformative impact of free AI-powered tools on the medical device industry. We discuss how making regulatory intelligenc…
10 months, 4 weeks ago
Colombia Medical Device Registration: Unpacking Decree 4725 of 2005
This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of …
10 months, 4 weeks ago
Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success
This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. W…
11 months ago
Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024
This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the k…
11 months ago
Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico
This episode provides a detailed overview of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. The host breaks down …
11 months ago
Navigating COFEPRIS: A Deep Dive into Mexico's 'Reglamento de Insumos para la Salud' for Medical Devices
This episode provides a detailed overview of Mexico's medical device regulations, focusing on the Reglamento de Insumos para la Salud. We explore the…
11 months ago
Mexico's COFEPRIS Framework: A Deep Dive into the Ley General de Salud for Medical Devices
This episode provides a comprehensive overview of Mexico's foundational health regulation, the Ley General de Salud, and its impact on medical device…
11 months ago
Brazil GMP Certification: A Deep Dive into RDC 687/2022 for Class III/IV Devices
This episode provides a detailed analysis of Brazil's RDC 687/2022, a critical regulation from ANVISA governing Good Manufacturing Practices (GMP) ce…
11 months ago
Navigating Brazil's ANVISA Technovigilance: A Deep Dive into RDC 67/2009 Reporting Timelines
This episode provides a detailed overview of Brazil's key technovigilance regulations for medical devices, RDC 67/2009 and RDC 551/2021. We explore t…
11 months ago
Brazil's BGMP Overhaul: Navigating ANVISA RDC 665/2022 and MDSAP Compliance
This episode explores Brazil's key regulation for medical device and IVD manufacturers, ANVISA RDC 665/2022. We break down the Brazilian Good Manufac…
11 months, 1 week ago