Podcast Episodes
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The Human Factor: A Practical Guide to IEC 62366-1 Usability Engineering
This episode demystifies the globally recognized standard IEC 62366-1:2015, which governs the application of usability engineering to medical devices…
1 year, 2 months ago
Unlocking Global Markets with the New Health Software Security Standard
This episode delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle ap…
1 year, 2 months ago
One Audit, Five Markets: Unlocking Global Access with MDSAP
This episode demystifies the Medical Device Single Audit Program (MDSAP), a framework allowing a single audit to satisfy the regulatory requirements …
1 year, 2 months ago
From FDA Clearance to TGA Inclusion: Navigating the Australian Medical Device Market
This episode details the specific steps and documentation required to list an FDA-cleared medical device on Australia's Australian Register of Therap…
1 year, 2 months ago
From FDA PMA to Health Canada: A Guide to Licensing High-Risk Medical Devices
Holding FDA PMA approval is a significant achievement, but what does it mean for entering the Canadian market? This episode breaks down the essential…
1 year, 2 months ago
From FDA 510(k) to EU CE Mark: Bridging the Regulatory Gap
Think your FDA 510(k) is a fast track to a European CE Mark? This episode uncovers the critical gaps between the two regulatory systems. We explore t…
1 year, 2 months ago
Leveraging Your FDA De Novo for Brazilian Market Access
This episode breaks down how to leverage an FDA De Novo grant to achieve medical device registration in Brazil with ANVISA. We explain that while the…
1 year, 2 months ago
Beyond FDA Clearance: A Guide to China's NMPA Medical Device Registration
This episode demystifies the process for registering an FDA-cleared medical device in China. We explore why FDA approval is only the first step and d…
1 year, 2 months ago
Beyond the Lab: Mastering Clinical Trials with ISO 14155:2020
This episode provides a detailed overview of ISO 14155:2020, the international standard for Good Clinical Practice in medical device investigations. …
1 year, 2 months ago
Navigating the New Rules of Medical Device Risk: ISO 14971:2019 Explained
This episode demystifies the latest version of the essential risk management standard, ISO 14971:2019. We explore the critical updates manufacturers …
1 year, 2 months ago