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
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Understanding the New FDA Draft Guidance for Chemical Characterization
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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
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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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When, Why, and How to Use Post-Market Clinical Follow-Up (PMCF) Surveys
Published: July 17, 2024
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