The Case for Chromogenic Agar in the Age of MALDI-TOF MS Posted on March 10, 2025 by Andy Chasteen […] Read More… from The Case for Chromogenic Agar in the Age of MALDI-TOF MS
Risk Management Guidance for Medical Devices Incorporating Machine Learning (ML) or Artificial Intelligence (AI) Posted on March 6, 2025 by Andy Chasteen […] Read More… from Risk Management Guidance for Medical Devices Incorporating Machine Learning (ML) or Artificial Intelligence (AI)
From Concept to Market: How the FDA’s Breakthrough Device Designation Works Posted on March 3, 2025 (March 4, 2025) by Andy Chasteen […] Read More… from From Concept to Market: How the FDA’s Breakthrough Device Designation Works
The Value of Internal Quality Audits Posted on February 9, 2025 (February 9, 2025) by Andy Chasteen […] Read More… from The Value of Internal Quality Audits
Key Points from the Nov 2024 FDA IVD Roundtable Posted on November 19, 2024 (November 22, 2024) by Andy Chasteen […] 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) by Andy Chasteen […] 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) by Andy Chasteen […] 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) by Andy Chasteen […] 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) by Andy Chasteen […] 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) by Andy Chasteen […] Read More… from FDA Updates MDUFA V User Fees for FY 2025