Guide to Clinical Evaluation Reports (CER) for Medical Devices
Published: April 17, 2025
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The Newly Applied European Health Technology Assessment (HTA) Regulation: Implications for Medical Devices
Published: April 9, 2025
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Navigating the Regulatory Journey of Combination Products: A Focus on Material Characterization
Published: March 28, 2025
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Guide to Post-Market Clinical Follow-up Requirements Under EU MDR (2017/745)
Published: March 18, 2025
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Impact of PFAS Regulations on Medical Devices
Published: March 11, 2025
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Periodic Summary Update Report (PSUR) & Post-Market Surveillance Report (PMSR) for MDR Compliance
Published: January 22, 2025
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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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Comparing US FDA vs EU MDR Medical Device Software Requirements
Published: August 13, 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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MHRA Statement of Policy Intent: International Recognition of Medical Devices
Published: June 13, 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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Best Practices for MDR-Compliant Clinical Evaluations
Published: May 2, 2024
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