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

Published: July 10, 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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MHRA Statement of Policy Intent: International Recognition of Medical Devices

Published: June 13, 2024

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An In-Depth Exploration of Reimbursement Billing Guides and Their Benefits

Published: June 12, 2024

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Understanding the Benefit-Risk Ratio in Clinical Reports: Avoiding 6 Common Mistakes

Published: June 5, 2024

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Preclinical Studies for Dental Bone Graft Devices – 510(k) Submissions

Published: May 29, 2024

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Understanding the New MDCG 2024-4 Guideline for IVD Safety Reporting

Published: May 21, 2024

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Microbial Identifications: Managing Bioburden Monitoring Results

Published: May 14, 2024

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A Product Development Plan For My Laboratory Developed Test

Published: May 10, 2024

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Navigating Medical Device Clinical Trial Site Selection: A Data-Driven Approach

Published: May 8, 2024

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Best Practices for MDR-Compliant Clinical Evaluations

Published: May 2, 2024

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