Essential Tips for Preparing for Your ISO 13485:2016 Stage 1 Audit
An ISO 13485:2016 audit is a comprehensive evaluation process conducted to verify that a medical device manufacturer’s quality management system (QMS) meets the requirements of the…
Understanding the FDA’s Small Entity Compliance Guide for the LDT Final Rule
The U.S. Food and Drug Administration (FDA) recently introduced the Small Entity Compliance Guide (SECG) to accompany the Laboratory Developed Tests (LDT) Final Rule. This initiative…
Navigating the FDA’s Final Rule on Lab-Developed Tests – LDTs
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…
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)…