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Navigating Biocompatibility in Early Feasibility Studies

Posted 5 months ago

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Exploring Equivalency in Biocompatibility

Posted 5 months ago

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Human Factors: Real Life Testing for Real Life Experiences

Posted 6 months ago

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Updates on the IVDR

Posted 8 months ago

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Risk Management, Clinical Evidence and Post-Market Reporting

Posted 9 months ago

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Talking Risk with Dr. Naveen Agarwal-Part 2

Posted 1 year ago

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Talking Risk with Dr. Naveen Agarwal-Part 1

Posted 1 year and 1 month ago

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Chemistry with the MFDS

Posted 1 year and 1 month ago

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New FDA Biocompatibility Guidance – Let’s Discuss

Posted 1 year and 2 months ago

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Clinical Investigations: Collecting Proof That Your Device is Safe and Effective

Posted 1 year and 3 months ago

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The EU IVDR: What Do You Need To Know?

Posted 1 year and 4 months ago

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Compliance Pitfalls of In Vivo Studies—How to Learn from the Mistakes of Others

Posted 1 year and 5 months ago

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RAQA Café Live! – RAPS EU Convergence and Effective MDR-Compliant Periodic Safety Update Reports

Posted 1 year and 6 months ago

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IVD Special – Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

Posted 1 year and 6 months ago

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Software in a Medical Device (SIMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

Posted 1 year and 7 months ago

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Refuse to Accept Policy and the Future of FDA Submissions

Posted 1 year and 8 months ago

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