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FDA eSTAR Program: Three Main Benefits
More than a year ago, we explained the main benefits of the FDA eSTAR Program for 510(k) and De Novo filings. This information remains accurate, and…
Navigating Healthcare Cybersecurity: Section 524B of the FD&C Act
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…
Streamlining Success: Rook Quality Systems’ Comprehensive Clinical Evaluation Services for Medical Device Clients
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…
RookQS and Grasp Health Forge Dynamic Partnership
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…
A Guide to Etiquette and Preparation for Your First FDA Audit
Mastering Your First FDA Audit: A Guide to Etiquette and Preparation Following the COVID-19 pandemic, there has been a significant increase in FDA inspections as inspectors…
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…
Understanding the FDA Changes to LDT Regulations
This post is part of a two-part series. You can read Part 1 here In the ever-evolving landscape of medical technology, the regulation of Laboratory Developed…
FDA’s Move to Lower 510(k) Submissions to Aid Virtual Health Care
Why did the FDA release this document? The guidance document “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring” introduces a new policy…