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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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When, Why, and How to Use Post-Market Clinical Follow-Up (PMCF) Surveys

Published: July 17, 2024

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Wound Care Laboratory Testing Requirements: Your Path to Compliance

Published: July 12, 2024

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Real-World PMCF Under the MDR: Cost Effective PMCF Strategies and Plans

Published: July 10, 2024

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Exploring Equivalency in Biocompatibility

Published: July 9, 2024

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MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

Published: July 1, 2024

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FDA Releases “Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles”

Published: June 26, 2024

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