Guide to Premarket Approval (PMA) vs. De Novo: Understanding the Differences and Strategy
Published: May 21, 2025
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Addressing Common Pitfalls in Clinical Study Protocols: Practical Solutions and Best Practices
Published: May 13, 2025
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Guide to Understanding FDA Preclinical Study Requirements for Medical Devices
Published: April 10, 2025
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Impact of FDA Changes on MedTech Research
Published: April 3, 2025
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FDA Real-World Evidence: What Does It Really Mean and How Does It Work?
Published: April 2, 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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FDA Premarket and Postmarket Medical Device Cybersecurity
Published: March 26, 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Understanding the New FDA Draft Guidance on Medical Device Chemical Characterization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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