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

Posted 5 months ago

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Exploring Equivalency in Biocompatibility

Posted 5 months ago

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MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

Posted 5 months ago

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

Posted 5 months ago

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Human Factors: Real Life Testing for Real Life Experiences

Posted 5 months ago

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Post-Market Clinical Follow-up in Action: A Practical Approach to EU MDR Compliance

Posted 6 months ago

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White Paper: Outsource Your Way to Operational Excellence

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MHRA Statement of Policy Intent: International Recognition of Medical Devices

Posted 6 months ago

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

Posted 6 months ago

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

Posted 6 months ago

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

Posted 6 months ago

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Lessons Learned: Notified Body Feedback Regarding Client Submissions

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

Posted 7 months ago

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Movement to Molecular Diagnostics for Infectious Disease

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Microbial Identifications: Managing Bioburden Monitoring Results

Posted 7 months ago

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The Impact of Shifting Site of Care on Clinical Research: A Vascular Office-Based Laboratory Approach

Posted 7 months ago

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