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Two medical professionals discussing patient charts in a hospital setting.

Video: What is the FDA’s Appetite for Non-Traditional Trial Design? | Part 1

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Video: What’s the Difference Between a Randomized Study vs. Single Arm Performance Goal?

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Video: Have You Argued Your Statistics with the FDA?

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Video: Are There Tracks Similar to Breakthrough for Fast-Tracking Payments from CMS?

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Video: What is the Average Timeframe to Get CMS Coverage?

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Video: What is the Average Time to Gain Regulatory Authorization?

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Video: What Criteria Does the FDA Use to Approve an IDE Submission?

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Person in a suit presenting to a group seated indoors, with papers in hand representing NAMSA's medical innovation

Video: Is There Communication Between CMS and the US FDA?

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A diverse group collaborates around a laptop at a table, representing NAMSA's expertise on go-to-market strategy

Video: Should You Challenge the FDA?

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Two people discussing documents at a wooden table with a laptop and calculator.

Video: FDA – Friend or Foe?

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How to Ensure Compliance with Good Clinical Practices (GCP) in Clinical Trial Imaging

Published: February 5, 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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Planning and Designing Medical Device Studies in Multiple Geographies

Published: January 15, 2025

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Two people in suits working on a laptop at a long table with pendant lights representing a NAMSA blog post about the difference between SiMD and SaMD

Components of Effective Clinical Trial Management

Published: November 20, 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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