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…
A Pre-Submission (Pre-Sub) is a type of Q-Submission used by medical device developers to seek feedback from the FDA on applications such as IDE, PMA, HDE,…
Machine learning (ML) revolutionizes the medical field by enabling faster disease detection, more accurate diagnoses, and personalized treatments. These advancements rely heavily on the vast amounts…
In an ever-evolving healthcare landscape, medical device software (SMD) remains at the forefront of technological advancements and regulatory scrutiny. During a recent webinar hosted by RookQS,…
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: A Guide to Etiquette and Preparation Following the COVID-19 pandemic, there has been a significant increase in FDA inspections as inspectors…