Podcast Episodes
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Navigating EU IVDR: A Deep Dive into Performance Evaluation for High-Risk IVDs
This episode provides a detailed breakdown of the three pillars of performance evaluation required under the EU's In Vitro Diagnostic Regulation (IVD…
8 months, 1 week ago
EU Medical Device Cybersecurity: Navigating MDCG 2019-16 Under MDR & IVDR
This episode delves into the critical requirements for medical device cybersecurity in the European Union. We explore the concept of "state of the ar…
8 months, 1 week ago
EU AI Act & MDR/IVDR: Decoding the New Dual Compliance Roadmap for AI Medical Devices
This episode explores the critical intersection of the new European Union AI Act and the existing Medical Device and In-Vitro Diagnostic Regulations …
8 months, 1 week ago
EU SaMD Regulations: Mastering App Store Compliance and 'Making Available' Rules
This episode explores the critical new regulatory focus from Europe's Medical Device Coordination Group (MDCG) on Software as a Medical Device (SaMD)…
8 months, 2 weeks ago
EU Legacy Devices: Navigating the 'Significant Change' Maze Under MDR & IVDR
This episode delves into the critical definition of a "significant change" for legacy medical devices and IVDs under the EU MDR and IVDR. We explore …
8 months, 2 weeks ago
Beyond the Barcode: Mastering MedTech UDI for EUDAMED & Global Markets
This episode delves into the complex realities of Unique Device Identification (UDI) strategy for medical devices. The host explores common blockers …
8 months, 2 weeks ago
EU MDR Vigilance & Trend Reporting: A Deep Dive into CAPA and FSCA Decisions
This episode explores the critical operational hotspots in medical device vigilance under regulations like the EU MDR. We examine the pressures for f…
8 months, 2 weeks ago
Beyond the Plan: Mastering PMS and PMCF Execution Under EU MDR
This episode explores the critical shift in regulatory focus from Post-Market Surveillance (PMS) planning to execution. We discuss why Notified Bodie…
8 months, 2 weeks ago
EU MDR Clinical Evidence: Mastering CERs, PMCF, and Equivalence Arguments
This episode delves into the stringent clinical evidence requirements under the European Union's Medical Device Regulation (MDR 2017/745). We explore…
8 months, 2 weeks ago
EU MDR & IVDR Certification: Navigating the Notified Body Capacity Crunch and Timeline Compression
This episode delves into the ongoing Notified Body capacity crisis for EU MDR and IVDR certification. Despite extended transition deadlines, signific…
8 months, 2 weeks ago