Despite the 2025 court decision vacating the FDA’s LDT Final Rule, labs and manufacturers aren’t off the hook. This article explores how the FDA is shifting enforcement to RUO labeling and IVD misuse to maintain oversight of unregulated diagnostics.
What is the difference between RA & QA?
What’s the Difference Between Quality Assurance and Regulatory Affairs? If you’re navigating compliance in a small or early-stage medical device company, chances are you’ve come across two essential terms: Quality Assurance (QA) and Regulatory Affairs (RA). These...
How to Hold a Management Review
Streamline your next management review with our free agenda template. Designed to meet both FDA and ISO 13485 requirements, it helps ensure compliance, clear documentation, and efficient oversight without starting from scratch.