Addressing Common Pitfalls in Clinical Study Protocols: Practical Solutions and Best Practices
Published: May 13, 2025
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Rethinking Cytotoxicity: Do Cytotoxicity Results Predict In Vivo Outcomes?
Published: April 23, 2025
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Impact of FDA Changes on MedTech Research
Published: April 3, 2025
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PMCF Best Practices: Strategies for Notified Body Approval
Published: March 25, 2025
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FDA Clinical Insights: A Panel Discussion
Published: December 10, 2024
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AI/ML SaMDs: Cybersecurity, Human Factors, and Privacy
Published: November 13, 2024
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Understanding the New FDA Draft Guidance for Chemical Characterization
Published: October 9, 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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Wound Care Laboratory Testing Requirements: Your Path to Compliance
Published: July 12, 2024
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Post-Market Clinical Follow-up in Action: A Practical Approach to EU MDR Compliance
Published: June 20, 2024
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The Impact of Shifting Site of Care on Clinical Research: A Vascular Office-Based Laboratory Approach
Published: May 14, 2024
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Clinical Data Requirements Under MDR: A Panel Discussion
Published: April 16, 2024
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Comprehensive Guidance On Reusable Medical Device Processing Requirements: Cleaning, Disinfection and Sterilization Validations
Published: January 25, 2024
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ISO 10993-17 2023 Update: What You Need to Know
Published: September 29, 2023
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The Chemical Characterization Puzzle: Is There a Solution?
Published: August 2, 2023
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Telling Your Medical Device’s Story to Regulatory Agencies
Published: April 19, 2023
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