Overview Artificial intelligence (AI) technologies have ushered in a new era in healthcare, fundamentally altering how medical decisions are made. These advancements extend across various domains…
Design Transfer is the critical process of moving a medical device from prototype or early development to full-scale production. It can be involved in scenarios such…
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…
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,…
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…
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…
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…
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…