Key Points from the Nov 2024 FDA IVD Roundtable Posted on November 19, 2024 (November 22, 2024) […] Read More… from Key Points from the Nov 2024 FDA IVD Roundtable
QSR to QMSR, FDA’s New Standard —By Incorporation: ISO 13485 Posted on October 23, 2024 (October 29, 2024) […] Read More… from QSR to QMSR, FDA’s New Standard —By Incorporation: ISO 13485
Enhancing Sepsis Care: Expediting Blood Culture Processing for Rapid AST Posted on September 30, 2024 (October 7, 2024) […] Read More… from Enhancing Sepsis Care: Expediting Blood Culture Processing for Rapid AST
Key IVD-wise Takeaways from ADLM 2024 Posted on September 12, 2024 (September 20, 2024) […] Read More… from Key IVD-wise Takeaways from ADLM 2024
PCCP: A New Option for Changes to Your 510(k) Posted on September 9, 2024 (October 4, 2024) […] Read More… from PCCP: A New Option for Changes to Your 510(k)
FDA Updates MDUFA V User Fees for FY 2025 Posted on August 9, 2024 (September 20, 2024) […] Read More… from FDA Updates MDUFA V User Fees for FY 2025
