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Key Components of a Biological Evaluation Plan (BEP)

Published: March 19, 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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Understanding the New FDA Draft Guidance on Medical Device Chemical Characterization

Published: March 14, 2025

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Impact of PFAS Regulations on Medical Devices

Published: March 11, 2025

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Video: Why Should You Advocate for Yourself with the FDA?

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Video: What are the 4 Types of FDA Q-Submissions?

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Video: What Happens When Your Lead Reviewer or Team Changes?

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Video: Pre-Submission Meetings-Should You Talk to the FDA or Not? | Part 2

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Video: Pre-Submission Meetings-Should You Talk to the FDA or Not? | Part 1

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Video: How Do You De-Risk Your Trial to Save Time?

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Video: What are the Stages of Clinical Trials?

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Video: What is the FDA’s Thoughts on Physician Experiential Data?

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Video: What is the FDA’s Appetite for Non-Traditional Trial Design? | Part 2

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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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