March 3, 2025
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup Ivo Flipse from MedQAIR co-hosted the European SaMD Meetup alongside
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February 18, 2025
South Korea Introduces First-Ever Generative AI Medical Device Guidelines
South Korea’s Ministry of Food and Drug Safety (MFDS) announced on January 24th that it has released the first-ever guidelines
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February 12, 2025
The European Commission Withdraws the Proposed AI Liability Directive
In a move that has taken many in the technology and legal sectors by surprise, the European Commission has withdrawn
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February 11, 2025
IMDRF Issues Guidance Documents on Good Machine Learning Practice and Software Risk
On Wednesday, the International Medical Device Regulators Forum (IMDRF) finalized two highly anticipated technical documents outlining guiding principles for good
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January 21, 2025
FDA Recognizes CVSS v4.0 What You Need to Know
The U.S. FDA (Food and Drug Administration) recognized the Common Vulnerability Scoring System (CVSS) v4.0 on December 23, 2024, as
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January 16, 2025
MDCG 2023-3 Rev. 2. Questions and Answers on Vigilance Terms
On January 7, 2025, the MDCG 2023-3, a guidance document from the Medical Device Coordination Group (MDCG) of the European
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January 14, 2025
FDA Unveils Draft Guidance and Webinar for AI-Enabled Medical Device Developers
The United States Food and Drug Administration (FDA) released a draft guidance document on January 6, 2025, outlining its recommendations
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January 2, 2025
Choosing Your PRRC and Authorised Representative for Effective Collaboration
Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated
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December 10, 2024
The Role of an Authorised Representative in Managing Manufacturer Data and Completing EUDAMED Registrations
As an Authorised Representative (AR) in the European Union (EU), the role encompasses critical responsibilities regarding the management of manufacturer
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