MDC Blog - MDC

Key Points from the Nov 2024 FDA IVD Roundtable

Posted on November 19, 2024 (November 22, 2024) by Andy Chasteen

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QSR to QMSR, FDA’s New Standard —By Incorporation: ISO 13485

Posted on October 23, 2024 (October 29, 2024) by Andy Chasteen

QS to QMSR Transition FDA ISO 13485

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Enhancing Sepsis Care: Expediting Blood Culture Processing for Rapid AST

Posted on September 30, 2024 (October 7, 2024) by Andy Chasteen

An abstract image representing speed and efficiency, expediting blood culture processing, featuring flowing waves of light in bright colors such as white, blue, and green.

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Key IVD-wise Takeaways from ADLM 2024

Posted on September 12, 2024 (September 20, 2024) by Andy Chasteen

ADLM 2024 IVDwise Takeaways

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PCCP: A New Option for Changes to Your 510(k)

Posted on September 9, 2024 (October 4, 2024) by Andy Chasteen

Changes to 510(k)

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FDA Updates MDUFA V User Fees for FY 2025

Posted on August 9, 2024 (September 20, 2024) by Andy Chasteen

MDUFA V user fees increasing

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Four New Rapid AST Solutions Hit the Market over Six Months

Posted on July 31, 2024 (August 2, 2024) by Andy Chasteen

Illustration - Antibiotic resistant Pseudomonas aeruginosa bacterium

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How to Build a Culture of Quality in Medical Device Organizations

Posted on May 24, 2024 (May 24, 2024) by Andy Chasteen

Creating a quality focused culture in ivd and medical device organizations

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FDA Finalizes Landmark Ruling: LDTs Officially Regulated as Medical Devices

Posted on April 30, 2024 (April 30, 2024) by Andy Chasteen

Final LDT Rule: FDA to Regulate LDTs as Medical Devices

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The FDA’s Reclassification of IVDs and Implications for LDTs

Posted on March 22, 2024 (March 22, 2024) by Andy Chasteen

FDA to Reclassify Majority of Class III IVDs to Class II

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