FDA Labeling Requirements for Point of Care vs. Home Use Devices
A critical decision in designing and developing a medical device is whether it will be used by trained professionals or the general population. This decision will…
A critical decision in designing and developing a medical device is whether it will be used by trained professionals or the general population. This decision will…
On April 29th, 2024, the FDA introduced its much-anticipated Final Rule on Laboratory Developed Tests (LDTs), marking a significant milestone in regulating in vitro diagnostics. This…
In our interconnected world, where medical devices are integral to patient care, cybersecurity stands as a paramount concern. The Food and Drug Administration (FDA), recognizing the…
Rook Quality Systems offers comprehensive clinical evaluation services to medical device clients, assisting clients with navigating the development and regulatory approval process. Our strategy emphasizes the…
Revolutionizing Global Medical Device Engineering Development Services Rook Quality Systems (RookQS), a forefront provider of quality and regulatory solutions, proudly announces its strategic collaboration with Grasp…
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…
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’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)…
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…