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Navigating Biocompatibility in Early Feasibility Studies

Published: July 30, 2024

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Exploring Equivalency in Biocompatibility

Published: July 9, 2024

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Human Factors: Real Life Testing for Real Life Experiences

Published: June 25, 2024

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Updates on the IVDR

Published: April 24, 2024

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Risk Management, Clinical Evidence and Post-Market Reporting

Published: March 6, 2024

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Talking Risk with Dr. Naveen Agarwal-Part 2

Published: December 13, 2023

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Talking Risk with Dr. Naveen Agarwal-Part 1

Published: November 27, 2023

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Chemistry with the MFDS

Published: November 15, 2023

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New FDA Biocompatibility Guidance – Let’s Discuss

Published: October 4, 2023

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

Published: September 14, 2023

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The EU IVDR: What Do You Need To Know?

Published: August 10, 2023

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

Published: July 12, 2023

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

Published: June 28, 2023

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

Published: June 14, 2023

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

Published: May 10, 2023

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Refuse to Accept Policy and the Future of FDA Submissions

Published: April 12, 2023

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