Podcast Episodes
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TGA Approval Down Under: A Guide to the 2002 Medical Device Regulations
This episode provides a comprehensive overview of Australia's medical device regulations, governed by the Therapeutic Goods Administration (TGA). We …
1 year, 1 month ago
Decoding NOM-241: Mexico's New GMP Framework for Medical Devices
This episode unpacks the crucial updates in Mexico's NOM-241-SSA1-2021, the mandatory standard for Good Manufacturing Practices for medical devices. …
1 year, 1 month ago
Argentina's MedTech Gateway: Unpacking ANMAT's Key Registration Rules
This episode demystifies Argentina's medical device registration process under the national regulatory body, ANMAT. We provide a detailed breakdown o…
1 year, 1 month ago
Colombian Market Entry: Your Guide to Decree 4725 and INVIMA
This episode provides a comprehensive guide to Colombia's medical device regulations, focusing on the foundational Decree 4725 of 2005 and the role o…
1 year, 1 month ago
Brazil's Regulatory Reset: A Guide to RDC 751/2022
This episode unpacks Brazil's landmark medical device regulation, RDC 751/2022. We explore the key updates that align Brazil with global standards, i…
1 year, 1 month ago
Navigating Europe's MedTech Shift: A Guide to EU MDR Compliance
This episode provides a dense overview of the EU Medical Device Regulation (MDR 2017/745), a pivotal shift in European MedTech compliance. We explore…
1 year, 1 month ago
EU IVDR: Navigating New Deadlines and Stricter Rules
The European Union's In Vitro Diagnostic Regulation (IVDR) has replaced the IVDD, introducing a stricter, risk-based classification system and increa…
1 year, 2 months ago
Navigating Canada's MedTech Market: A Guide to the CMDR
Canada's medical device market is a significant opportunity, but navigating its regulatory framework, the CMDR (SOR/98-282), is essential for market …
1 year, 2 months ago
EU Clinical Trial Blueprint: Unpacking the MDCG 2024-3 Guidance
This episode dissects the critical MDCG 2024-3 guidance issued in March 2024, which outlines the European Union's expectations for a Clinical Investi…
1 year, 2 months ago
Navigating the UKCA Transition: Key Deadlines for Medical Device Manufacturers
This episode breaks down the essential requirements of the UK MDR 2002, outlining the critical transition deadlines for moving from CE marking to the…
1 year, 2 months ago