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A Guide to ISO 10993-18’s Analytical Evaluation Threshold

Published: November 21, 2024

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Components of Effective Clinical Trial Management

Published: November 20, 2024

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Enhancing Chemical Characterization with the CLAP Database

Published: November 14, 2024

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AI/ML SaMDs: Cybersecurity, Human Factors, and Privacy

Published: November 13, 2024

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Understanding the New FDA Draft Guidance for Chemical Characterization

Published: October 9, 2024

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Making the Most of the Evolving Q-Sub Program

Published: October 3, 2024

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2 Regulatory Standards That Ensure Medical Devices are Transported and Stored Safely

Published: October 3, 2024

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What is the Difference Between SiMD and SaMD?

Published: October 2, 2024

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EU MDR and IVDR: Classifying Medical Device Software (MDSW)

Published: September 25, 2024

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FDA’s Regulation of AI/ML SaMD

Published: September 25, 2024

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AI/ML and SaMD Medical Devices: New and Unique Challenges in Getting to Market

Published: September 25, 2024

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Published: August 13, 2024

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Bioburden Testing vs. Sterility Testing: What Is The Difference?

Published: August 6, 2024

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Medical Device Reimbursement Payer Research: Key Areas of Payer Research

Published: July 31, 2024

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Navigating Biocompatibility in Early Feasibility Studies

Published: July 30, 2024

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Summary of Safety and Clinical Performance Best Practices

Published: July 24, 2024

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