A Guide to Etiquette and Preparation for Your First FDA Audit
Mastering Your First FDA Audit Following the COVID-19 pandemic, there has been a significant increase in FDA inspections as inspectors strive to catch up with the…
Guidelines for Verifying Laboratory Testing Data Before FDA Submission
FDA’s Response to Data Integrity Issues The FDA recently expressed concern regarding the rise of fraudulent and unreliable laboratory testing data in premarket submissions. The agency…
FDA Proposes New Regulations For Laboratory Developed Tests
FDA’s Proposal for LDT Regulation In a collaborative effort to enhance the safety and effectiveness of Laboratory Developed Tests (LDTs), the Food and Drug Administration (FDA)…
6 Bold Predictions for Medical Device Quality in 2024
As we step into the new year, we asked our team members to share their insights by forecasting five daring trends in medical device quality for…
Rook QS Joins Forces with Trust Cybersecurity for Unparalleled Defense
Rook Quality Systems (RookQS), a leading provider of quality solutions, is proud to announce its strategic partnership with Trust Cybersecurity, a specialized cybersecurity testing service catering…