Don’t Wait – Schedule Your 2024 Internal Audit with RookQS Today!
As 2024 wraps up, many companies are scrambling to complete their internal audits before the end of the year. The internal audit process plays a vital…
Understanding How to Properly Evaluate Suppliers per FDA Requirements 21 CFR 820.50
Purchasing Controls and Supplier Evaluations are a critical component of quality management for medical device manufacturers, ensuring that materials, components, and services provided by third parties…
Small Business Determination Requests Now Accepted Through CDRH Portal
The FDA recently released a significant update to its Center for Devices and Radiological Health (CDRH) Portal, allowing medical device companies to send premarket submissions and…
The FDA’s Artificial Intelligence Program’s Role in Addressing Regulatory Challenges in AI-Driven Medical Devices
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…
Key Strategies for Successfully Executing the Design Transfer Process
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…
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…
What is A Pre-Submission (Pre-Sub)?
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,…
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…
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…